Original Article

Cosmetic
The Effectiveness of Immediate Triamcinolone
Acetonide Injection after Auricular Keloid Surgery:
A Prospective Randomized Controlled Trial
Chairat Burusapat, MD, FRCST

Nutthapong Wanichjaroen, MD, Background: The earlobe and helix are common sites for keloids following ear
FRCST piercing. First-line therapy involves intra-keloidal excision followed by triamcino-
Nuttadon Wongprakob, MD, lone acetonide (TA) injection. Yet, the optimal timing for TA injection after keloid
FRCST excision remains debated. The objective of this study was to compare outcomes
Rapeepat Sapruangthong, MD between immediate and delayed TA injection after auricular keloid excision.
Methods: This was a prospective, controlled trial with patients randomized into
immediate or delayed groups. The Vancouver Scar Scale (VSS) and Patient and
Observer Scar Assessment Scale (POSAS) were used to evaluate scar quality. The
number of recurrent keloid cases was recorded, defined as a VSS height of 3,
POSAS thickness greater than 5, or an increase in VSS height or POSAS thickness
after keloid excision. Overall complications were recorded. A P value less than
0.05 was considered statistically significant.
Results: The immediate group contained 18 patients, and the delayed group had
16 patients. The mean age of patients was 25.52 years, and the mean maximum
keloid diameter was 14.49 mm (7–32.5 mm). The immediate group reported a sta-
tistically significant lower recurrence rate than did the delayed group at 5 months
(P = 0.042). No significant differences were noted between VSS and POSAS scores
at 3 months, and no complications were recorded during the study.
Conclusions: Immediate TA injection is an acceptable option for auricular keloid
treatment. Here, it was associated with a lower recurrence rate than with delayed
injection and resulted in no complications. The immediate and delayed groups had
similar outcomes for VSS and POSAS. (Plast Reconstr Surg Glob Open 2021;9:e3729;
doi: 10.1097/GOX.0000000000003729; Published online 4 August 2021.)

INTRODUCTION and helix. Auricular keloids could result from trauma or

A keloid is a fibroproliferative disorder that can result ear piercing, with a 2.5% incidence rate.2
from the alteration of growth factor regulation, aberrant Current keloid therapeutic management has many
collagen turnover, genetic abnormalities, immune dys- modalities, including surgical, medical, physical, radiother-
function, sebum reaction, or mechanical factors. It fea- apeutic, and experimental options.3 Intralesional triamcin-
tures abnormal deposition of hyalinized collagen bundles, olone acetonide (TA) injection is the most effective and the
resulting in firm, fibrous nodules, papules, or plaques.1 first-line treatment for mature keloids. TA, a synthetic cor-
Keloids cause disfiguration, psychological problems, ticosteroid, has been used either alone or in combination
and functional impairment that affect patient quality of with surgery, pressure, or radiation, with varying results.
life. The most common auricular keloid sites are the lobe TA injection alone and in combination with lesion exci-
sion are the most common treatment options for auricular
keloids.4 The recurrence rate of an excised keloid alone is
45%–100%, whereas it is less than 50% if postoperative TA
From the Division of Plastic and Reconstructive Surgery, Department injection is included.5–8 Intralesional TA injection could
of Surgery Phramongkutklao Hospital and Phramongkutklao be done in a variety of ways.9
College of Medicine, Bangkok, Thailand. TA reduces collagen synthesis. It decreases X2-
Received for publication January 11, 2021; accepted June 8, 2021. macroglobulins and X1-antitrypsin by promoting col-
Copyright © 2021 The Authors. Published by Wolters Kluwer Health, lagenase inhibitor activity, altering extracellular matrix
Inc. on behalf of The American Society of Plastic Surgeons. This components such as glycosaminoglycans, and increasing
is an open-access article distributed under the terms of the Creative pro-inflammatory mediators, the production of β1 by
Commons Attribution-Non Commercial-No Derivatives License 4.0 human dermal fibroblasts, endogenous vascular endothelial
(CCBY-NC-ND), where it is permissible to download and share the
work provided it is properly cited. The work cannot be changed in Disclosure: The authors have no financial interest to declare
any way or used commercially without permission from the journal. in relation to the content of this article.
DOI: 10.1097/GOX.0000000000003729

www.PRSGlobalOpen.com 1
 PRS Global Open • 2021

growth factor, and interleukin-1 (IL-1).10 Corticosteroids study. We recorded demographic data, including age, sex,
induce an increased production of β-fibroblast growth fac- body mass index, and smoking habits, and keloid-related
tor (β-FGF). Intralesional TA injection reduces fibroblast information such as duration, maximum diameter, loca-
activity, density, and maturation.11,12 Moreover, immediate tion, etiology, and previous treatments.
TA injection was reported to reduce pro-α1 (I) collagen
gene expression.13 It is possible that TA, administered Randomization
immediately after the excision, could prevent keloid recur- The patients were randomly allocated to the following
rence. However, rare complications such as infection were groups by a random numbers table:
reported following immediate TA injection. 1. Immediate group: defined as patients receiving an
Previous studies were inconclusive on the best tim- intraoperative injection of 0.1–0.2 mL 10 mg/mL TA
ing of TA injection after keloid excision, immediate or into the incision after keloid excision.
delayed.11,12,14 Therefore, elucidating this point was the 2. Delayed group: defined as patients receiving 0.1–
objective of this study.11–14 0.2 mL 10 mg/mL TA injection into the incision 1
This study aimed to compare immediate and delayed week after the keloid excision surgery.
single TA injection in terms of scar quality using the
Vancouver Scar Scale (VSS) and the Patient and Observer The total dose of TA was also decided depending on
Scar Assessment Scale (POSAS) over a follow-up period of 6 the length of suture line (0.1 mL per 1 cm).
months. Moreover, complications such as pain, skin atrophy,
depigmentation, and telangiectasias were assessed to deter- Procedure Preparation
mine the proper TA injection timing after keloid excision. The surgical site was prepared under sterile condi-
tions. The intralesional keloid excision surgery was per-
formed under local anesthesia with 1% xylocaine HCl.
PATIENTS AND METHODS The skin was closed with 6-0 nylon suture without tension
This prospective randomized controlled trial was con- and by the nontraumatizing technique (Fig.  1), and no
ducted from September 2017 to September 2019. The eth- oral antibiotic was dispensed.
ics committee of Phramongkutklao Hospital and College
of Medicine approved this study. All patients provided Evaluation
informed consent. The outcomes were recorded and evaluated by a
surgeon who was blinded to the study group allocation.
Patient Selection Images were acquired with a camera (model Rx100 mark
The inclusion criteria were as follows: patients with iv with 20.1 megapixels Exmor RS CMOS Sensor and
auricular keloids, aged 18–65 years, with pathological Bionz X image processor; Sony Corp., Tokyo, Japan).
tissue reports confirmed by a pathologist, and agreed to The focal distance was approximately 30 cm. We recorded
provide their informed consent for participation. The the VSS and POSAS scores, any complications, recurrent
exclusion criteria were as follows: patients with a history of keloid timing, and tissue pathology.
TA hypersensitivity or anaphylaxis, immunocompromised
patients, those who underwent a previous treatment over Scar Assessment
the past year, patients using steroid or immunosuppres- Surgical scars were evaluated by the VSS and POSAS.
sive drugs, and patients who refused to participate in the VSS evaluated pain, itching, pigmentation, vascularity,

Fig. 1. Immediate TA injection after intralesional keloid excision. A, Patient with a 1.0 x 3.0-cm left helix-auricular keloid. B, Intrakeloidal
excision was performed with primary intension. C, 0.1 ml 10 mg/ml TA was injected at suture line.

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Burusapat et al. • TA Injection after Keloid Surgery

height, and pliability. POSAS is a reliable and valid scar Table 1. Demographic Data
assessment scale that measures scar quality from two per-
spectives: the patient and the clinician. The patient POSAS IG (n = 18) DG (n =16) P
includes itching, pain, irregularity, color difference, stiff- Gender 0.134*
 Men 3 (16.67) 7 (43.75)
ness, and thickness; the clinician POSAS includes vascular-  Women 15 (83.33) 9 (56.25)
ity, pigmentation, thickness, relief, pliability, and surface Age 20.5 (18–66) 24 (17–33) 0.616†
area. Body mass index 21.64 ± 3.61 23.41 ± 5.26 0.080†
Smoking 0.387*
 No 16 (88.89) 12 (75.00)
Follow-up Procedure  Yes 2 (11.11) 4 (25.00)
Location 0.125*
All patients were invited to the clinic 7 days postop-  Antihelix 0 1 (6.25)
eratively. The surgical site was evaluated in both groups,  Helix 12 (66.67) 6 (37.50)
and TA was injected in the delayed group. The sutures  Lobule 6 (33.33) 9 (56.25)
Duration (mo) 12 (6–60) 18 (8–48) 0.446‡
were removed on postoperative day 14. VSS, POSAS, and Maximum diameter (mm) 14.1 (7–32.5) 12.2 (7–29) 0.523‡
complications were recorded monthly for 6 months in Etiology 1*
both groups. A surgical scar was observed until the keloid  Infection 1 (5.56) 1 (6.25)
 Piercing 17 (94.44) 15 (93.75)
recurred or till the end of the 6 months. Recurrent keloids Previous treatment 1*
were injected monthly with TA. Keloid recurrence was  No 16 (88.89) 14 (87.50)
 Yes 2 (11.11) 2 (12.50)
defined as a VSS height score of 3 or patient-POSAS thick- *
Fisher exact test.
ness score of 5 or higher. Alternatively, recurrence was †
Independent t-test.
determined when we detected a postoperative increase in ‡
Mann-Whitney U test.
the VSS height score or POSAS thickness score. VSS and P < 0.05 is considered significant.
DG, delayed group; IG, immediate group.
POSAS scores were not calculated after keloid recurrence.

Endpoints significantly higher VSS height and pliability scores than

The primary outcome was the total recurrence rate by the immediate group in the first 2 months.
the 6-month follow-up visit. The secondary outcome was
complications after treatment, including infection and POSAS
skin flap necrosis. The POSAS scores 6 months after the surgery were
similar in both groups. However, the immediate group
Statistical Analysis showed a significantly higher POSAS thickness score at
The outcomes of this study were demographic data, VSS postoperative months 2 and 3.
and POSAS scores, and complication and recurrence rates.
These were compared by the Pearson chi-squared test, Recurrence Rate
Fisher exact test, independent samples t-test, or the Mann- Auricular keloid recurred within 6 months in four
Whitney U test, as appropriate. The confidence interval for patients in the immediate group (22.2%), which is signifi-
statistical data was 95%, and differences were considered cantly less than that in the nine patients in the delayed
statistically significant at a P value less than 0.05. group (56.25%; Table  2 and Fig.  2). Figure  3 shows a
recurrent keloid after excision.

RESULTS Complications
Patient Demographics There were no complications such as infection, skin
Thirty-four patients were enrolled between September flap necrosis, inflection, postoperative bleeding/hema-
2017 and September 2019. Eighteen patients were allo- toma, skin atrophy, or telangiectasias.
cated to receive an immediate TA injection, and 16
received a delayed TA injection. The patient demograph- DISCUSSION
ics are listed in Table  1. The median age was 24.7 years Immediate TA injection after keloid excision is a
(range, 18–33 years), and the study population consisted safe and effective method to reduce the recurrence
of 10 men (29.4%) and 24 women (70.6%). The keloid rate. However, surgeons often dread using it because
site distribution included the helix in 18 patients (53%), of the potential postoperative complications. This
lobule in 15 patients (44%), and antihelix in one patient study is the first randomized controlled trial to com-
(3%). The mean maximum diameter was 14.48  mm pare immediate and delayed TA injections after keloid
(range, 7.0–32.5 mm). All keloids were located above the excision.
supra-perichondrial plane. The mean body mass index A previous study reported unsatisfactory keloid treat-
was 21.94 kg/m2 (range 16.5–34.8 kg/m2). The auricular ment with a high recurrence rate.14 Surgery and TA
keloid etiology was piercing in 32 patients (94%) and injection have shown varying recurrence rates (Table 3).
infection in 2 (6%). It ranged between 50% and 100% in cases of excision
alone.15 Berman and Flores reported that recurrence
VSS following postoperative TA injection started within
The VSS scores 6 months after the surgery were simi- 7 days of excision (58.5%), and this recurrence rate
lar in both groups. However, the delayed group showed was similar to excision alone (51.2%).22 Sclafani et al

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 PRS Global Open • 2021

Table 2. Accumulate Number of Recurrence

Duration No. Immediate No. Delayed Accumulate Number Accumulate Number
(mo) Group Group of Recurrence—IG of Recurrence—DG P*
1 18 (100%) 16 (100%) — —
2 18 (100%) 13 (81.25%) — 3 0.094
3 16 (88.88%) 12 (75.00%) 2 4 0.374
4 14 (77.77%) 9 (56.25%) 4 7 0.180
5 14 (77.77%) 7 (43.75%) 4 9 0.042†
6 14 (77.77%) 7 (43.75%) 4 9 0.042†
*Pearson Chi-squared test.
†Significant if P < 0.05.
DG, delayed group; IG, immediate group.

Fig. 2. Accumulated recurrence number in the immediate and delayed groups.

Fig. 3. A recurrent auricular keloid 4 months after excision and immediate TA injection. (A) A 2-month
postoperative photograph. (B) photograph obtained 4 months postoperatively showing recurrent
keloid.

4
 Table 3. Results of the Systematic Literature Review
Mean Number Postoperative
No. of Administered Follow-up Recurrence
Study Method Keloids Site Treatment Regimen Injections Duration (mo) Rate (%) Results
Singleton and — 54 Ear Immediate methylprednisolone — 12 7% —
Gross15 acetate 32–40 mg or TA 8 mg and
continued monthly for 12 months
Kiil16 Prospective trial 15 Whole Combined excision and immediate TA — 24–60 86.70% —
body injection therapy
17
Barton — 19 Ear 10–15 mg of TA injection at — 6–48 0% —
immediate postoperative and
postoperative day 7
Shons and — 31 Ear 0.1–0.2 mL of 40 mg/mL of TA — 35 3% —
Press18 injection at postoperative week
3 and repeated twice at 4-week
intervals
Tang19 Case report study 11 Whole Intra- and postoperative weekly steroid — 12–36 18% —
body injection (10–30 mg Triamcinolone
suspension)
Salasche and A surgical technique: 6 Ear Immediate 5 mg/mL of TA injection — >12 0% —
Grabski20 circular incision and and postoperative 2 week and then
plane separation of the subsequent injections are given at
central core of keloid 4- to 6-week interval as needed
Sclafani et al21 Randomized trial 12 Ear 0.4 mL of 40 mg/mL of TA at — 19 33.30% —
postoperative days 7, 21, and 35
Berman and Retrospective study 65 Whole TA group 10–40 mg/mL (started 1.4 7.5 58.50% —
Burusapat et al. • TA Injection after Keloid Surgery

Flores22 body within 7days of excision)

16 IFN-α2b — 7.9 18.70% —
43 Excision only — 6.5 51.20% —
Tan23 Patient-controlled 17 Whole 4 weeks Postoperative TA injection of — 3 16 of 17 showed
comparative body 0.1–0.5 mL of 40 mg/mL 50% reduction in
clinical trial volume at week
12
Jung et al24 — 18 Ear Preoperative intralesional TA 5.2 18.5 16.67% —
injections were administered twice
at 1-month interval: 0.1– 1.0 mL of
TA (20–40 mg/mL); postoperative
intralesional TA injection was
started at 2 weeks time point after
surgery and injection was given
every 1 month for several months
Srivastava Single-blind, randomized 60 Whole TA group received intralesional TA of — Every 3 weeks till 24 — Lowest survival
et al25 parallel group study body 40 mg/mL weeks or till the curves for
keloid is resolved vascularity of VSS
5-FU group received intralesional — Every 3 weeks till 24 — Lowest survival
5-FU of 50 mg/mL weeks or till the curves for height
keloid is resolved of VSS
TA+5-FU group received intralesional — Every 3 weeks till 24 — Short term: lowest
injection of a combination of TA weeks or till the survival curves
(40 mg/mL) and 5-FU (50 mg/mL) keloid is resolved for pliability and
at a ratio of 1:9 pigmentation of
VSS

(Continued)

5
 PRS Global Open • 2021

reported a recurrence rate of 33% after a delayed serial

40 mg/mL TA injection following earlobe keloid exci-

TA was associated
with significant

compared with
improvement

and pliability
in vascularity
sion.21 Chowdri et al reported a recurrence rate of 8.1%
Results

Verapamil
in intraoperative and serial postoperative corticosteroid
—

—
injection therapy.30 Surgical excision with postoperative
intralesional TA injection is an effective auricular keloid
treatment. Immediate TA injection after keloid excision
in our study reduced the recurrence rate. Young et al
Recurrence

In progress
Rate (%)

showed that immediate TA injection after keloid exci-

22.20%

56.25%
0%

5%

—
sion resulted in lower pro-alpha (I) collagen transcript
expression, higher production of β-fibroblast growth fac-
tor (β-FGF), lower production of transforming growth
factor 1 (TGF-1) by the dermal fibroblasts, endogenous
vascular endothelial growth factor, and IL-1, and thin-
Duration (mo)
Postoperative

ner and less dense collagen bundles than the surgery

Follow-up

15.93

alone group.31,32
24
—

6
TA should be used with caution because intralesional
corticosteroid injections were reported to be associated
with various side effects in 63% of the patients.33 Local
side effects include infection, atrophy, depigmentation,
and telangiectasia. Cushing syndrome and menstrual dis-
of Administered
Mean Number

turbances are rare systemic complications. Ketchum et

Injections

4.22

3.59

al reported that 95% of these complications result from

—

incorrect TA injections.34
This study aimed to compare single-dose immediate
and delayed TA injections after keloid surgery. We did
Second postoperative week 0.1–0.5 mL

not use the subsequent TA injection method to avoid dis-

Immediate 10 mg/mL of TA injection
10 mg/mL TA will be administered

20 mg/mL was administered once

intralesional injection of TA from

(concentration of 10–40 mg/mL)

turbance of effects between doses. However, all patients

Cesarean Sub-dermal injection of 2 ampule

First postoperative week 4–10 mg

per month for several months

received monthly TA injections after a 6-month follow-up

Treatment Regimen

period. Additionally, this study showed the real effective-

10 mg/mL of TA injection at

ness of single-dose immediate and delayed of TA within 6

months. No additional records were taken after 6 months
postoperative day 7

because subsequent TA injections are known to disturb

every 4–6 weeks
at a single dose

the effectiveness of the first-dose TA. The recurrence rate

in this study was very high because we used the VSS and
POSAS scores. Moreover, we redefined recurrence for
early detection, and for dual detection between physicians
and patients.
—

Our study suggests that immediate TA injection after

keloid excision results in a lower recurrence rate than
incision
section

Whole
body
Site

Ear

Ear

Ear

delayed TA injection. Immediate TA injection after exci-

sion showed no complications. The VSS height and pli-
ability scores were higher in the first 2 months, and the
Keloids

POSAS thickness score was higher in the second and third

No.

150

31

20

15

34

months in the immediate group. However, the VSS and

POSAS scores were similar for both groups at the end of
randomized controlled

the study (Fig. 4).

This study was limited by the small number of partici-
Systemic review and
Retrospective study

pants. Furthermore, the follow-up period was insufficient

controlled trial
Method

retrospective,
trial protocol

meta-analysis
clinical study

to make definitive assertions about auricular keloid recur-

A randomized
A single blind

Single-center,

rence after treatment.

Table 3. (Continued)

CONCLUSIONS
Immediate TA injection after keloid excision was a
safe and effective technique for auricular keloid treat-
Zhuang et al29
Mohammadi

ment with a follow-up of 6 months. Its advantages include

Chua et al26

Choi et al28

Our study

a lower recurrence rate than the delayed TA injection

et al27

group and no complications. VSS and POSAS scores at the

Study

final follow-up were similar in the two groups. However,

6
Burusapat et al. • TA Injection after Keloid Surgery

Fig. 4. A, Patient with a 1.0 x 3.0-cm keloid at left helical rim. B, A 6-month postoperative photograph.

the VSS height and pliability and the POSAS thickness 9. Butler PD, Longaker MT, Yang GP. Current progress in keloid
scores in the immediate TA injection group were higher research and treatment. J Am Coll Surg. 2008;206:731–741.
in the first few months. 10. McCoy BJ, Diegelmann RF, Cohen IK. In vitro inhibition
of cell growth, collagen synthesis, and prolyl hydroxylase
Rapeepat Sapruangthong, MD activity by triamcinolone acetonide. Proc Soc Exp Biol Med.
Division of Plastic and Reconstructive Surgery 1980;163:216–222.
Department of Surgery 11. Berman B, Maderal A, Raphael B. Keloids and hypertrophic
Phramongkutklao Hospital and scars: Pathophysiology, classification, and treatment. Dermatol
Phramongkutklao College of Medicine Surg. 2017;43(suppl 1):S3–S18.
315 Ratchawithi Road, Thung Phayathai 12. Hochman B, Locali RF, Matsuoka PK, et al. Intralesional triam-
Ratchathewi, Bangkok 10400 cinolone acetonide for keloid treatment: A systematic review.
Thailand Aesthetic Plast Surg. 2008;32:705–709.
E-mail: [email protected] 13. Kauh YC, Rouda S, Mondragon G, et al. Major suppression of
pro-alpha1(I) type I collagen gene expression in the dermis after
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