Comparing The Treatment Outcomes of Absorbable Sutures, Nonabsorbable Sutures, and Tissue Adhesives in Cleft Lip Repair: A Systematic Review

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Original Article

The Cleft Palate-Craniofacial Journal


2022, Vol. 59(1) 110–120
Comparing the Treatment Outcomes of ª 2021, American Cleft Palate-
Craniofacial Association

Absorbable Sutures, Nonabsorbable Article reuse guidelines:


sagepub.com/journals-permissions
DOI: 10.1177/1055665621996107
Sutures, and Tissue Adhesives in Cleft Lip journals.sagepub.com/home/cpc

Repair: A Systematic Review

Uchenna P. Egbunah, BDS1 , Olawale Adamson, BDS2 ,


Azeez Fashina, BDS2, Adegbayi A. Adekunle, BDS1 ,
Olutayo James, BDS2, and Wasiu L. Adeyemo, PhD2

Abstract
Objectives: To examine the literature and synthesize the available reports for the best possible option between absorbable,
nonabsorbable, and tissue adhesives in cleft lip skin closure.
Design: We conducted systematic searches for randomized controlled trials and controlled clinical trials in PubMed, Cochrane,
Ovid Medline, and OpenGrey databases. Identified studies were retrieved and assessed for eligibility. All statistical analyses were
done with Revman, version 5.4.
Interventions: The intervention considered in this systematic review were techniques of cleft lip repair using resorbable sutures,
nonabsorbable sutures, medical adhesives, or any combination of these.
Outcome Measures: The primary outcomes assessed in the trials had to include any combination of the following: wound healing
cosmesis and wound healing complications. While secondary outcomes considered were quality of life, direct and indirect costs
to patients and health services, and participant satisfaction.
Results: Only 6 studies met all inclusion criteria and were selected for qualitative analysis. A more favorable wound healing
cosmesis was seen when nonabsorbable suture was used in cleft lip repair compared to absorbable sutures and tissue adhesives
(CI, 0.65-4.35). This advantage was overshadowed by the significantly higher prevalence of postoperative complications when
nonabsorbable sutures are used.
Conclusion: Although the results point to more favorable cosmesis with nonabsorbable sutures and an overall more
favorable outcome with either absorbable sutures or tissue adhesives, the 6 selected studies were assessed at an
unclear risk of bias; therefore, the results of this study should be interpreted with caution and regarded as low-certainty
evidence.

Keywords
absorbable suture, nonabsorbable suture, tissue adhesives, cleft lip repair, systematic review

Introduction
1
Department of Oral and Maxillofacial Surgery, Lagos University Teaching
Orofacial clefts (OFC) encompass a range of congenital Hospital, Idi, Araba, Lagos, Nigeria
abnormalities of the orofacial region, which commonly pre- 2
Department of Oral and Maxillofacial Surgery, College of Medicine,
sents as cleft lip with or without palate (CLP) or isolated cleft University of Lagos, Lagos, Nigeria
palate (CP). Orofacial cleft is recognized as the most common
Corresponding Author:
craniofacial diagnoses in humans, with a worldwide prevalence Olawale Adamson, Department of Oral and Maxillofacial Surgery, College of
of 1.2 per 1000 live births (Oginni & Adenekan, 2012) but can Medicine, University of Lagos, Lagos 100254, Nigeria.
be up to 1 per 700 live births (Shkoukani et al., 2013). Email: [email protected]
Egbunah et al 111

Cleft lip repair is complicated by the distortion of multiple cleft lip skin closure. Outcomes evaluated included cosmesis,
anatomical structures, including the skin and muscle attach- complications, and ease of surgical care.
ments of the upper lip, columella, nasal floor, and alar, which
can occur with varying severity. The goal of CLP repair is to
address the functional and cosmetic deformity of CLP (De La
Methodology
Pedraja et al., 2000). In order to achieve such goals, the repair This systematic review and meta-analysis were conducted
should include the creation of an intact and appropriately sized and presented according to the methods of the Cochrane
upper lip to compensate for the loss of philtral height on the guideline for systematic reviews (Akl, 2019) and according
cleft side, repair of the underlying muscular structure for nor- to the protocol registered in the PROSPERO 2018 database:
mal oral competence and function, and primary repair of nasal CRD42020202893.
deformity in complete cleft cases (De La Pedraja et al., 2000).
Another major aspect in the management of CLP is the Eligibility Criteria
follow-up period as esthetic results from definitive surgical
Types of studies. Only randomized controlled trials (RCTs) and
repair are only evident after some time has passed (Shkoukani
controlled clinical trials (CCTs) as described by the authors in
et al., 2013). Therefore, it may be necessary for the patient to
the manuscript methodology comparing either resorbable
return to the operating room for revisions to improve function
sutures to nonabsorbable sutures or comparing medical adhe-
and appearance of the repair (Pham & Senders, 2006). Facial
sives to any type of sutures were included in this systematic
cosmetic results are one of the most concerning issues for the
review.
parents of patients with cleft lip. Moreover, the postoperative
care of the surgical site, the discomfort associated with the Types of participants. Participants were individuals of all ages,
suture removal, and additional visit for suture removal are other but majorly included children less than 1 year of age with
reasons that encourages one to use any new treatment method confirmed diagnoses of CLP.
that may replace the need for suture placement and removal
(Shkoukani et al., 2013). Types of interventions. The intervention was any technique of
These concerns have led to recent changes in practices char- cleft lip repair using resorbable sutures, nonabsorbable sutures,
acterized by some surgeons advocating the use of absorbable medical adhesives, or any combination of these. We also
sutures in place of the traditionally used nonabsorbable sutures, included secondary cleft lip repair and revisit cleft lip repair
eliminating the need for suture removal postoperatively, which cases.
often necessitates sedation or general anesthesia (Choudhary &
Types of outcome measures. The outcomes assessed in the trials
Cadier, 2000; Kudur et al., 2009). Studies have also proposed
had to include any combination of the following:
the use of tissue adhesives as an adjunct technique for skin
Primary outcomes:
closure as opposed to sutural cleft lip repair (Knott et al.,
2007; Collin et al., 2009). These studies showed that adhesives,  Wound healing cosmesis
such as Dermabond (J & J Healthcare Systems), offer equiva-  Wound healing complications
lent mature wound cosmesis similar to traditional suture clo-
sure in the repair of cleft lip and have the added benefit of Secondary outcomes:
avoiding additional dressing changes or suture removal under
 Quality of life
sedation (Knott et al., 2007; Collin et al., 2009).
 Direct and indirect costs to patients and health services
Results of the above studies (Choudhary & Cadier, 2000;
 Participant satisfaction
Knott et al., 2007; Collin et al., 2009; Kudur et al., 2009)
emphasize the need to determine which of these treatment
options provide the best treatment outcome in terms of wound Search Strategy and Selection of Studies
healing cosmesis, postoperative complications, and postopera- We conducted systematic searches for RCTs and CCTs in
tive surgical care. Despite several studies (Choudhary & PubMed (NLM), Cochrane, Ovid Medline, and OpenGrey
Cadier, 2000; Knott et al., 2007; Collin et al., 2009; Kudur databases. The US National Institutes of Health Ongoing Trials
et al., 2009) elucidating the need to understand these compara- Register (ClinicalTrials.gov) and the World Health Organiza-
tive outcomes, to our knowledge, there has been no systematic tion (WHO) International Clinical Trials Registry Platform
review of the available evidence to provide an evidence-based (WHO clinical trials registry) were also searched for ongoing
decision on the best option for cleft lip repair based on the and past studies. Additional searches were done; the reference
above parameters. Such evidence will inform clinical decisions sections of eligible studies were hand-searched for other rele-
regarding the choice of material for cleft lip repair as this will vant studies and purposeful Google Scholar searches for rele-
lead to a more favorable treatment outcome. Therefore, the aim vant additional studies were done. Only articles written in
of this systematic review was to examine the literature and English or with English language translations were considered
synthesize the available reports for the best possible option for the review. There were no publication conditions. All data-
between absorbable, nonabsorbable, and tissue adhesives in bases were searched to June 2020.
112 The Cleft Palate-Craniofacial Journal 59(1)

Figure 1. Flowchart of the study search strategy and selection process.

The first 2 authors (U.P.E. and O.A.) independently the first 2 authors (U.P.E. and O.A.) to establish whether
screened the titles and abstracts (when available) of all or not the studies met the inclusion criteria. Disagreements
reports identified through the electronic searches. The were resolved by a third review author (A.A.A.). The
search was designed to be sensitive and included RCTs search strategies and search terms used, as well as the
and CCTs. Noncontrol clinical trials, retrospective cohorts, exclusion criteria for selection of studies are illustrated
and cross-sectional studies were filtered out in the selec- in Figure 1.
tion process. As studies involving CLP are often included
with those of Mendelian syndromes such as van der Woude
syndrome, we undertook a broad search to include all pos- Data Extraction and Management
sible studies. For studies appearing to meet the inclusion Two review authors (U.P.E. and A.A.A.) independently
criteria, or for which there were insufficient data in the extracted data from the included studies without disagreement.
title and abstract to make a clear decision, we obtained the The data extraction forms were piloted on several papers and
full report. The full reports were independently assessed by modified as required before use.
Egbunah et al 113

For each study, we recorded the following data (where Assessment of heterogeneity. Meta-analyses was conducted only
available): for similar studies with similar comparisons reporting the same
outcome measures. We assessed the significance of any dis-
 Authors name, year of publication, year of first partici- crepancies in the estimates of the treatment effects from the
pant recruitment, country of origin, study design, and different studies using the Higgins Index (I2; Whitehead et al.,
source of funding 2004) and we investigated any heterogeneity.
 Sociodemographic characteristics of participants, cri-
teria for inclusion and exclusion, characteristics of Data synthesis. We combined mean and SD using random-effect
CLP (unilateral, bilateral; partial, complete; palatal (RE) models. Random-effect models summary estimates were
involvement; syndromic, nonsyndromic), duration of preferred to fixed effects to achieve the most conservative
review, evaluation of wound cosmesis, presence of estimates. Standardized mean difference was used as effect
postoperative complications, and ease of postopera- measure in preference to mean difference because similar out-
tive surgical care comes were measured with different methods and scales. Meta-
 Details of treatment duration, dosage, cost, and analysis was only conducted for combinable data. Variables
follow-up that determined combinability included primary lip repair, type
 Details of the outcomes evaluated, including assessment of absorbable sutures used (polyfilament), outcome evaluated,
measures and time intervals follow-up period, and type of assessment (professional). Due to
the different natural history and treatment regimens for CLP,
we planned to analyze different CLP types separately, if pos-
Assessment of Risk of Bias in Included Studies sible. All statistical analyses were done with Revman, version
5.4 (Cochrane, 2020).
We independently assessed the risk of bias in included studies
using a design-specific risk of bias tool modified from the
adapted risk of bias criteria for individual studies in systematic Results
reviews of health care intervention by Viswanathan et al.
(2008). We proposed 7 criteria for the assessment: (1) sequence Description of Studies
generation (selection bias), (2) allocation method (selection We identified 58 research papers through our database search
bias), (3) performance bias, (4) attrition bias, (5) detection bias, after inclusion of all the key words and removal of all duplicate
(6) reporting bias, and (7) other bias. studies. We retrieved full-text copies of these articles for
detailed review. Additional searches were also done. Finally,
Statistical Analysis only 6 trials (Shinohara et al., 1996; Spauwen et al., 2006;
Bhuiyan et al., 2010; Datarkar et al., 2014; Rao et al., 2016;
Measures of treatment effect. The primary outcome most fre-
Alawode et al., 2018) met all inclusion criteria, and they were
quently and reliably reported was post-op cosmesis, measured
selected for qualitative analysis. A total of 299 participants who
via the Visual Analog Scale (VAS). Visual Analog Scale was
underwent CLP repair were included in the outcome evalua-
first described in 1921 and referred to at the time as a “graphic
tions. Of the 6 trials included in this review; 5 (Shinohara et al.,
rating method” (Okitsu et al., 2014). They are psychometric
1996; Bhuiyan et al., 2010; Datarkar et al., 2014; Rao et al.,
response scales used to measure subjective characteristics or
2016; Alawode et al., 2018) compared resorbable sutures with
attitudes and have been used in the past for a multitude of
nonabsorbable sutures and only 1 (Spauwen et al., 2006) com-
disorders, as well as in market research and social science
pared tissue adhesives with resorbable sutures. Table 1 details
investigations, among others. (A Comparison of Multi-Item
characteristics of included studies.
Likert and Visual Analogue Scales for the Assessment of Trans-
actionally Defined Coping Function, n.d.; Funke, 2004.) In this
case, it tells us the characteristics of the physical appearance of Risk of Bias of Included Studies
the postsurgical lip repair based on the assessment of parents or The risk of bias of included studies was assessed via the design-
the managing physicians. Also, in some studies, the Hollander specific risk of bias modified from the adapted risk of bias
Wound Evaluation Scale was used by the managing physician criteria for individual studies in systematic reviews of health
to evaluate cosmetic outcome (Quinn J et al., 1997; Ong et al., care intervention by Viswanathan et al. (2008). Of the 6 trials, 3
2002; Wan et al., 2014). were RCTs (Datarkar et al., 2014; Rao et al., 2016; Alawode
We entered these data into the meta-analysis using the gen- et al., 2018) and 3 were CCTs (Shinohara et al., 1996; Spauwen
eric inverse variance method. For each outcome reported, the et al., 2006; Bhuiyan et al., 2010).
mean and SD for each group and P values were extracted or
calculated based on the methods proposed by Parmar and col- Sequence generation (selection bias). Of the 3 RCTs, 2 (Datarkar
leagues (Parmar &Torri, 1998). For studies reporting median et al., 2014; Alawode et al., 2018) reported adequate randomi-
and range, we planned to estimate mean and SD using the zation sequence generation methods and were assessed as
currently most accepted method in the literature for this pur- being at low risk of bias for this domain. In 1 trial (Rao
pose by Elbourne et al. (2002) and Wan et al. (2014). et al., 2016), the method of sequence generation was unclear
114
Table 1. Characteristics of Selected Studies.
Sample size
Study Design Age range
Author, year Country Surgery type Type of CLP Treatment protocol and technique Treatment groups Outcome evaluated follow-up Evidence/result

Resorbable vs nonabsorbable sutures


Alawode et al., 201822 Randomized controlled N ¼ 60 Unilateral cleft lip and Surgical repair under GA (N ¼ 57) 1.5 metric Ethicon-coated Vicryl Wound healing complications, POD 3, 7, 14: Vicryl vs nylon
First patient recruited trial (32 males, 28 females) alveolus (N ¼ 23) Surgical repair under LA (N ¼ 3) (Polyglactin 910) 4/0 suture, including hemorrhage, Hemorrhage: 3.3%, 0%, 0% vs
May 2013 Single center 3 Months to 48 years Unilateral cleft lip and palate Dressing: Sufra-Tulle gauze cutting needle 17.5 mm tissue reactivity, wound 0%, 0%, 0% (no P value)
Nigeria (68% <1 year) (N ¼ 26) Surgical repair UCLP: MRA (N ¼ 30) dehiscence, local wound Tissue reactivity: 40%, 40%, 6.7%
Primary and Bilateral cleft lip and alveolus or TRT 1.5 metric Nylon 4/0 suture, infection. vs 26.7%, 6.7%, 0% (P value ¼
secondary repair (N ¼ 3) Surgical repair BCLP: MFFT cutting needle 17.5 mm; POD 3, 7, 14 .27, .002, .49, respectively)
Bilateral cleft lip and palate removed POD 7 (N ¼ 30) Wound dehiscence: 10%, 6.7%,
(N ¼ 8) 3.3% vs 6.7%, 3.3%, 3.3%
(P value ¼ 1.0, 1.0, 1.0,
respectively)
Infection: 3.3%, 3.3%, 0% vs 0%,
0%, 0% (no P value)
Shinohara et al, 199623 Controlled clinical trial N ¼ 103 Unilateral and bilateral CLP Treatment protocol and technique Absorbable material N ¼ 47: Wound cosmesis No significant difference in
First patient recruited Single center (sex distribution not (sample size per type not for surgical repair not stated. (Polydioxanone N ¼ 43, Wound healing complication; cosmetic appearance of scars
1990 (month not Japan stated) stated) Material for dressing not stated. polyglyconate N ¼ 2, or both stitch abscess between both groups
stated) Age distribution not N ¼ 2) 12 months (quantitative data not given)
stated Nonabsorbable (buried Stitch abscess: Nylon 14% >
Primary repair monofilament nylon); removed absorbable 0% (P value ¼
at POD 5 (N ¼ 56) .007)
Rao et al 201624 Randomized controlled N ¼ 20 (sex Nonsyndromic unilateral cleft Surgical repair under GA for all Absorbable suture Wound cosmesis (hypo/ POD 7, 30, 180, and 1 year:
First patient trial distribution not lip complete or patients (GA or sedation also material (Vicryl Rapide or hyperpigmentation, Vicryl vs nylon
recruitment date Single center stated) incomplete (sample size used for suture removal in the irradiated Polyglactin 910; hypertrophic scar, Hypo/hyperpigmentation: 10%,
not stated India 3-18 months per type not stated) nylon group) N ¼ 10) abnormal scar pliability) 40%, 70%, 60% vs 20%, 60%,
Primary repair Modified MRA technique and Nonabsorbable suture material Infection: 20%, 10% (P value ¼ .277,
primary rhinoplasty (for (nylon or polyamide; removed 1 week, 1 month, 3 months, .361, .002, .010, respectively)
complete CLP) used for all at POD 7 (N ¼ 10) 6 months, 1 year Hypertrophic scar: 10%, 70%,
patients 70%, 60% vs 0%, 30%, 20%,
20% (P value ¼ .165, .098,
.008, .036, respectively)
Abnormal scar pliability: 80%,
80%, 70%, 50% vs 80%, 50%,
30%, 10% (P value ¼ .330,
.292, .021, .104, respectively)
Infection: At POD 7; 0% Vicryl <
10% nylon (P value >.05)
Datarkar et al, 201425 Randomized controlled N ¼ 60 (no difference All patients had unilateral Surgical repair under GA for all CLP repair using absorbable suture Wound cosmesis (measured Mean VAS (Vicryl vs prolene) 1
First patient recruited trial in sex of primary cleft lip patients (GA or sedation also (Vicryl Rapide; N¼ 30) via 100-mm VAS) month, 6 months, 1 year:
June 2010 Single center participant) used for suture removal in the CLP repair using nonabsorbable Wound healing complication 88.27, 88.27, 91.93 vs 91.17,
India Mean age of 3 months prolene group) suture (Prolene); removed at (infection, dehiscence, 91.17, 93.17 (P value >.05)
Primary repair Standard MRA technique used for POD 7 (N ¼ 30) hypertrophic scar) Wound infection: Vicryl (6.67%)
all patients 1 month, 6 months, 1 year vs prolene (6.67%),
P value >.05
Wound dehiscence: Vicryl (0%)
vs prolene (10%),
P value >.05
Hypertrophic scar: Vicryl
(3.33%) vs prolene (3.33%),
P value >.05

(continued)
Table 1. (continued)
Sample size
Study Design Age range
Author, year Country Surgery type Type of CLP Treatment protocol and technique Treatment groups Outcome evaluated follow-up Evidence/result
26
Bhuiyan et al, 2010 Controlled clinical trial N ¼ 26 (15 males, UCLP (central CLP ¼ 1, Surgical repair under GA for all CLP repair using absorbable suture Wound cosmesis (measured by Excellent wound cosmesis: IRPG
First patient recruited Multicenter (2) 11 females) lateral CLP ¼ 25). patients (GA used for suture (fast absorbable irradiated clinical examination) 910 (91.6%) < polypropylene
January 2003 Bangladesh 3 months to 10 years Patients with UCLP with removal only in 71.5% of Polyglactin 910; N ¼ 12) Discomfort (pain/itching) (92.9%), P value >.05
Primary repair grossly deformed face and patients in the polypropylene CLP repair using nonabsorbable Participant/parent) satisfaction Discomfort: IRPG 910 (16.7%) <
UCLP with major group) suture (polypropylene); Total cost polypropylene (21.4%),
associated anomaly were Standard MRA technique used for removed at POD 7 (N ¼ 14) 4 weeks P value <.05
excluded from the study lateral defects. For central Participant satisfaction: IRPG
defect, linear closure was done 910 (100%) > polypropylene
(35.7%), P value <.01
Cost of suture material: IRPG
910 (300taka) >
polypropylene (200taka),
P value <.01
Cost of hospital stay: IRPG 910
(200taka) < polypropylene
(700taka), P value <.001
Extra cost for suture removal:
1000taka
Medical adhesives vs resorbable sutures
Spauwen et al, 200627 Controlled clinical trial N ¼ 30 (16 males, Unilateral cleft lip and/or Surgical repair under GA for all Intradermal sutures at midlevel Wound cosmesis (measured Mean VAS parents assessment:
First patient Single center 14 females) alveolus (N ¼ 12) patients of the lip (Monocryl 6.0) via 100-mm VAS) Dermabond (81.33) >
recruitment date Netherlands 5.3-6.4 months Unilateral cleft lip and palate Surgical repair UCLP: MRA and Dermabond (octyl-2- Complications at 8 weeks Monocryl 6.0 (80.87),
not stated Primary repair (N ¼ 10) Surgical repair BCLP: Manchester cyanoacrylate) at epidermal Complications at 2.2 years, P value ¼ .922
Bilateral cleft lip and palate type of closure level. N ¼ 15 8 weeks, 1.8-2.7 years Mean VAS professionals
(N ¼ 8) 4 intradermal plus 2-3 epidermal (mean 2.2 years) assessment: Dermabond
sutures of Monocryl 6.0. (65.12) > Monocryl 6.0
N ¼ 15 (64.9), P value ¼ .983
Complications at 8 weeks:
Suture granuloma: Dermabond
(0%) < Monocryl 6.0 (6.7%),
P value >.05
Hyperpigmentation:
Dermabond (20%) <
Monocryl 6.0 (40%),
P value >.05
Hypertrophic scar: Dermabond
(20%) < Monocryl 6.0
(26.7%), P value >.05
Complications at 1.8-2.7 years:
Suture granuloma: Dermabond
(13.3%) < Monocryl 6.0
(20%), P value ¼ .624
Hyperpigmentation/
hypertrophy: Dermabond
(40%) > Monocryl 6.0 (20%),
P value ¼ .232
Overall complications at *2.2
years: Dermabond (53.3%) >
Monocryl 6.0 (40%),
P value ¼ .273

Abbreviations: BCLP, bilateral cleft lip and/or palate; GA, general anesthesia; LA, local anesthesia; MFFT, Millard fork flap technique; MRA, Millard rotation advancement; POD, postoperative day; TRT, Tennison-Randall
technique; UCLP, unilateral cleft lip and/or palate; VAS, Visual Analog Scale.

115
116 The Cleft Palate-Craniofacial Journal 59(1)

and was assessed as being at unclear risk of bias. One CCT


(Spauwen et al., 2006) reported adequate strategy for recruiting
participants and was assessed as being at low risk of bias for the
sequence generation domain while the remaining 2 CCTs
(Shinohara et al., 1996; Bhuiyan et al., 2010) were assessed
at an unclear risk of bias.

Allocation method (selection bias). Of the 3 RCTs, only 1 (Datar-


kar et al., 2014) reported adequate allocation concealment and
was assessed as being at low risk of bias for this domain. The 3
CCTs (Shinohara et al., 1996; Spauwen et al., 2006; Bhuiyan
et al., 2010) did not report their strategies for including parti-
cipants and were assessed as being at unclear risk of bias for
this domain.

Performance bias. Blinding of participants and clinicians is not


feasible in surgical trials and was not assessed. In the 6 trials
assessed, researchers ruled out any impact from concurrent
interventions and unintended exposures and maintained fidelity
to their intervention protocol. They were assessed as being at
low risk of bias for this domain.

Attrition bias. We assessed 6 trials as being at low risk of bias


with regard to incomplete outcome data because all the parti-
cipants were adequately accounted for in the outcome
evaluation.

Detection bias. Only 1 trial (Spauwen et al., 2006) stated blind-


ing of outcome assessment by evaluators and was assessed at a
low risk of bias for this domain.

Reporting bias. We assessed 6 trials as free of selective reporting


bias as they reported on expected, prespecified clinically Figure 2. Risk of bias summary: Review authors’ judgments about
important outcomes. each risk of bias item for each included study.

Other bias. We assessed 6 trials at low risk of other bias because (2010) compared irradiated Polyglactin 910 sutures to polypro-
the intervention groups appeared to be similar at baseline. pylene sutures in CLP repair.
Overall bias. All trials were assessed at an unclear risk of bias
for the outcomes evaluated. Also, the studies reported the use Wound healing cosmesis. Rao et al. (2016) measured wound
of different sutures materials that react differently with soft healing cosmesis in terms of the presence or absence of abnor-
tissue conferring additional overall bias on qualitative analy- mal pigmentation, hypertrophic scar, and abnormal scar plia-
sis. A summary of the risk of bias assessment is presented in bility. A significant difference favoring cosmesis of
Figure 2. nonabsorbable suture group was seen in abnormal pigmenta-
tion measured at 3 months and 1 year (P ¼ .002, .010, respec-
tively); hypertrophic scar measured at 3 months and 1 year
Effects of Intervention (P ¼ .008, .036); and abnormal scar pliability measured at
Comparison 1: Resorbable sutures versus nonabsorbable sutures. 3 months (P ¼ .021). In the trial by Datarkar et al. (2014),
Five trials (Shinohara et al., 1996; Bhuiyan et al., 2010; Datar- wound healing cosmesis was measured via100-mm VAS
kar et al., 2014; Rao et al., 2016; Alawode et al., 2018) com- (Okitsu et al., 2014) and reported to be more favorable in the
pared the use of resorbable sutures with nonabsorbable sutures nonabsorbable suture group compared to the resorbable suture
in CLP repair. The trial by Alawode et al. (2018) compared 4/0 group. This difference was, however, not statistically signifi-
Vicryl (Polyglactin 910) sutures to 4/0 nylon sutures; the trial cant (P > .05). The trial by Bhuiyan et al. (2010) measured
by Shinohara et al. (1996) compared polydioxanone and poly- wound healing cosmesis by clinical examination and also
glyconate sutures to monofilament nylon sutures; the trial by reported a difference favoring the nonresorbable suture group
Rao et al. (2016) compared Vicryl sutures to nylon sutures; the that was not statistically significant (P > .05). The trial by
trial by Datarkar et al. (2014) compared Vicryl sutures to pro- Shinohara et al. (1996) reported that there was no significant
lene (polypropylene) sutures; and the trial by Bhuiyan et al. difference in cosmetic appearance of scars between the
Egbunah et al 117

resorbable and nonabsorbable suture groups but did not give measured at POD 7 by the attending physician. Test of overall
any quantitative data. The trial by Alawode et al. (2018) did not effect did not show any statistically significant difference in the
report wound healing cosmesis. rate of complications between the 2 groups measured at POD 7.
Figure 3 represents the meta-analysis of absorbable and non-
Wound healing complications. Infection was the most common absorbable comparison.
wound healing complication reported. Alawode et al. (2018)
reported 3.3% infection rate in the Vicryl group and no infec- Comparison 2: Medical adhesives versus resorbable sutures. Only 1
tion in the nylon group (no P value given). Rao et al. (2016) study (Spauwen et al., 2006) compared the use of medical
reported a difference in rate of infection favoring the Vicryl adhesives with resorbable sutures in skin apposition of CLP
group (P > .05). Datakar et al. (2014) reported an equal rate of repair. The trial by Spauwen et al. (2006) compared the use
infection in both groups (P > .05). Shinohara et al. (1996) of intradermal Monocryl 6/0 sutures and Dermabond (octyl-2-
reported infection in terms of stitch abscesses and showed a cyanoacrylate) at epidermal level for CLP repair with the use of
statistically significant difference of higher recorded infection Monocryl 6/0 sutures.
in the nonabsorbable suture group (P ¼ .007). The trial by
Wound healing cosmesis. Spauwen et al. (2006) reported
Bhuiyan et al. (2010) did not report on infection.
Two trials (Datarkar et al., 2014; Alawode et al., 2018) wound healing cosmesis measured by both the parents and the
professional via the 100-mmVAS (Okitsu et al., 2014). There
reported contradictory results for wound dehiscence. The trial
was no significant difference between the overall cosmetic
by Alawode et al. (2018) reported more wound dehiscence in
result of medical adhesive (81.33; 65.12) and resorbable
the resorbable suture group (P ¼ 1.0), while the trial by Datar-
sutures (80.87; 64.9) judged by both parents and professionals,
kar et al. (2014) reported more wound dehiscence in the non-
respectively (P ¼ .922, .983, respectively).
absorbable suture group (P > .05). Hypertrophic scar assessed
at 1 year post-CLP repair was regarded as a complication. Wound healing complications. In the trial by Spauwen et al.
Datarkar et al. (2014) reported an equal prevalence of hyper- (2006), immediate complications like suture granuloma (0%,
trophic scar in both groups (P > .05), while Rao et al. (2016) 6.7%), hyper pigmentation (20%; 40%), and hypertrophic scar
reported a statistically significant increase in the presence of (20%; 26.7%) were recorded less in the Dermabond group
hypertrophic scar in the resorbable suture group (P ¼ .036). compared to the Monocryl suture group, respectively. How-
Other complications such as hemorrhage (no P value given) ever, overall complications measured between 1.8 and 2.7
and tissue reactivity (P ¼ .002) measured at postoperative day years showed a complication predilection favoring the Derma-
(POD) 7 were reported to be higher in the resorbable suture bond group (53.3%) compared to the Monocryl suture group
group by Alawode et al. (2018), while pain/discomfort was (40%). Both results were not statistically significant (P > .05).
reported to be significantly lower (P < .05) in the resorbable
suture group by Bhuiyan et al. (2010). Secondary outcomes. The trial by Spauwen et al. (2006) did
not report secondary outcomes.
Secondary outcomes. Only the trial by Bhuiyan et al. (2010)
Quantitative analysis. No quantitative analysis was done for
reported secondary outcomes. Patient satisfaction was signifi-
this group due to insufficient data.
cantly higher in the resorbable suture group (P < .01) and
overall cost to participants was significantly higher in the non-
absorbable suture group (P < .01). Though the cost of resorb- Discussion
able suture material is higher than that of the nonabsorbable,
the overall costs involved for repeated visits, suture removal, This systematic review was undertaken to answer the question,
and anesthesia required in the nonabsorbable suture group are “Between absorbable sutures, nonabsorbable sutures, and med-
quite higher than those of the resorbable suture group. ical adhesives, which will give the best clinical outcome when
used for CLP repair?” Some studies (Choudhary & Cadier,
Quantitative analysis. Quantitative analysis for all the differ- 2000; Collin et al., 2009; Kudur et al., 2009) have reported
ent outcomes was based on a generic inverse variance method an improved clinical outcome when CLP repair is performed
and RE model using log odds and the SE data entry. For cosm- with absorbable sutures and/or tissue adhesives over nonab-
esis, only 3 studies (Bhuiyan et al., 2010; Datarkar et al., 2014; sorbable sutures, while others have reported an inconclusive
Rao et al., 2016) fulfilled the criteria for combinability report- result (Knott et al., 2007; Alawode et al., 2018). Therefore, an
ing cosmesis result of polyfilament absorbable sutures com- evidence-based answer to this question will guide clinical and
pared with nylon/prolene sutures measured at 1 year surgical practices and also lead to an improved surgeon and
postoperation by the attending physician. Test of overall patient/parent satisfaction after CLP repair. Six trials with a
effect of the pooled data showed a statistically significant dif- total of 299 participants with CLP were included. All included
ference in cosmesis favoring the nonabsorbable suture group trials had an overall unclear risk of bias.
(P < .008). For overall complications, only 3 studies (Datarkar Several studies (Choudhary & Cadier, 2000; Magee et al.,
et al., 2014; Rao et al., 2016; Alawode et al., 2018) fulfilled the 2003; Mourougayan, 2006; Paige, 2006; Collin et al., 2009;
criteria for combinability reporting complications of polyfila- Knott et al., 2007; Kudur et al., 2009; Ruotolo & Fearon,
ment absorbable sutures compared with nylon/prolene sutures 2009; Cooper & Malhotra et al., 2016) have advocated the
118 The Cleft Palate-Craniofacial Journal 59(1)

Figure 3. Forest plots of the main quantitative analysis for absorbable sutures versus nonabsorbable sutures showing estimates of each
outcome for individual studies, and the pooled estimates of all studies alongside their risk of bias assessments.

elimination of the suture removal stage as this would help were reported in the qualitative analysis of other complications
reduce cost to patients from additional dressing and anesthe- such as wound dehiscence, hypertrophic scar, and hemorrhage.
sia/sedation, as well as limit the risk of complications arising No significant difference was noted in the meta-analysis of
from multiple visits. Five trials (Shinohara et al., 1996; Bhui- overall complication rate measured at POD 7. A significant
yan et al., 2010; Datarkar et al., 2014; Rao et al., 2016; Ala- difference in cost and patient satisfaction was also noted
wode et al., 2018) that compared the use of only resorbable (P < .01) favoring the resorbable suture group.
sutures with the use of only nonabsorbable sutures in CLP Also, several studies (Magee et al., 2003; Cooper & Paige,
repair were included. In qualitative analysis of wound healing 2006; Mourougayan, 2006; Ruotolo & Fearon, 2009; Malhotra
cosmesis, 1 trial (Rao et al., 2016) reported a statistically sig- et al., 2016) have advocated the use of tissue adhesives for CLP
nificant difference in favor of the nonabsorbable arm, whereas repair due to certain advantages such as satisfactory wound
the remaining trials did not report any statistically significant healing cosmesis, reduced surgery time compared to suturing
difference between the 2 groups. After meta-analysis, a statis- technique, limited patient discomfort through elimination of
tically significant difference in wound healing cosmesis mea- suture removal stage, and simplified postoperative care. This
sured at 1 year post-CLP repair was noted favoring the review involved only 1 trial (Spauwen et al., 2006) that com-
nonabsorbable arm (P ¼ 0.008). This result, however, should pared the use of absorbable intradermal sutures and tissue adhe-
be interpreted with caution and regarded as low-certainty evi- sives for skin apposition for CLP repair. Qualitative analysis
dence because the pooled data from combined studies had a reported no significant difference in both wound healing cosm-
high degree of heterogeneity (I2 ¼ 90%; P < .0001), which esis and complication rate measured over short- and long-term
could have affected the result. periods between both groups. Meta-analysis was not conducted
Conflicting results were seen in the qualitative analysis of as only 1 study fulfilled the inclusion criteria.
infection rate and no significant difference was noted between Although we planned to analyze different CLP types sepa-
the 2 groups. Stitch abscess, however, was reported to be sig- rately (unilateral, bilateral; complete, incomplete; with or with-
nificantly more prevalent in the nonabsorbable suture group out palatal involvement; syndromic, nonsyndromic), the
(P ¼ .007) and this usually occurred when sutures were left included studies did not delineate treatment outcomes based
beyond POD 7 (Shinohara et al., 1996). Inconclusive results on CLP type, making it impossible to do so.
Egbunah et al 119

Conclusion Datarkar AN, Rewanwar D, Rai A. Comparative analysis of unilateral


cleft lip closure using absorbable and nonabsorbable sutures: a
Although the results of this review point to a more favorable randomised clinical study. Plastic Aesthet Res. 2014;1(2):54-57.
wound healing cosmesis for nonabsorbable sutures, similar and doi:10.4103/2347-9264.139700
satisfactory wound healing cosmesis for absorbable sutures with De La Pedraja J, Erbella J, McDonald WS, Thaller S. Approaches to
or without tissue adhesives, a significantly higher prevalence of cleft lip and palate repair. J Craniofac Surg. 2000;11(6):562-571.
postoperative complications and poor patient satisfaction for doi:10.1097/00001665-200011060-00009
nonabsorbable sutures, and an overall more favorable outcome Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington H V,
for either absorbable sutures or tissue adhesives, the 6 selected Vail A. Meta-analyses involving cross-over trials: methodologi-
studies were assessed at an unclear risk of bias. Therefore, the
cal issues. Int J Epidemiol. 2002;31(1):140-149. doi:10.1093/ije/
results of this study should be interpreted with caution and
31.1.140
regarded as low-certainty evidence. Also, the results of this
Knott PD, Zins JE, Banbury J, Djohan R, Yetman RJ, Papay F. A
review were based on only 6 studies due to low quantity of pub-
comparison of Dermabond tissue adhesive and sutures in the pri-
lications available on RCTs in wound closure following cleft lip
mary repair of the congenital cleft lip. Ann Plast Surg. 2007;58(2):
surgery. A more robust number of studies with low level of bias
121-125. doi:10.1097/01.sap.0000232984.68797.62
would have been a better indicator. This emphasizes the need for
Kudur MH, Pai SB, Sripathi H, Prabhu S. Sutures and suturing tech-
more RCTs on surgical wound closure following cleft lip repair.
niques in skin closure. Indian J Dermatol Venereol Leprol. 2009;
Declaration of Conflicting Interests 75(4):425-434. doi:10.4103/0378-6323.53155
Magee WPJ, Ajkay N, Githae B, Rosenblum RS. Use of octyl-2-
The author(s) declared no potential conflicts of interest with respect to
cyanoacrylate in cleft lip repair. Ann Plast Surg. 2003;50(1):1-5.
the research, authorship, and/or publication of this article.
doi:10.1097/00000637-200301000-00001
Funding Malhotra V, Dayashankara Rao JK, Arya V, Sharma S, Singh S,
Luthra P. Evaluating the use of octyl-2-cyanoacrylate in unilateral
The author(s) received no financial support for the research, author-
ship, and/or publication of this article. cleft lip repair. Natl J Maxillofac Surg. 2016;7(2):153-158. doi:10.
4103/0975-5950.201364
ORCID iDs Mourougayan V. Sutureless skin closure for cleft lip repair. Cleft
Uchenna P. Egbunah, BDS https://orcid.org/0000-0002-3354-9732 Palate-Craniofacial J. 2006;43(6):656-658. doi:10.1597/05-171
Olawale Adamson, BDS https://orcid.org/0000-0002-0904-6772 Oginni F, Adenekan A. Prevention of oro-facial clefts in developing
Adegbayi A. Adekunle, BDS https://orcid.org/0000-0001-5679- world. Ann Maxillofac Surg. 2012;2(2):163. doi:10.4103/2231-
4469 0746.101346
Okitsu H, Sawamura J, Nishimura K, Sato Y, Ishigooka J. A compar-
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