Volume 2, Issue 2, Spring 2002

SURGICAL GOWN REQUIREMENTS CAPTURE:

A Design Analysis Case Study

Traci May-Plumlee and Amanda Pittman

Department of Textile and Apparel, Technology and Management
North Carolina State University
Emails: [email protected] [email protected]

ABSTRACT

Design is a process best undertaken through an organized effort and a problem solving
approach. Understanding the complex set of requirements that must be addressed by a successful
new product, be they end user, legal, financial or other requirements, demands extensive
research. Design analysis is a major thrust of the research. This paper presents a method for the
existing product design analysis component of the functional design process utilizing a case study
of surgical gowns.

KEYWORDS: Surgical gown, functional design, design process, medical textile

INTRODUCTION design analysis with a clarification of the

Successful creation of functional term “functional apparel”. All apparel items
apparel products requires a disciplined, must meet minimal functional requirements
structured approach to design and including being supported by the body and
development. An effective, integrated allowing some degree of body movement.
approach progresses through investigation of Likewise, all apparel products meet at least a
the design problem, delineation of design minimal range of aesthetic requirements
requirements and critical analysis of those such as color and texture. Therefore, it is
requirements before arriving at a design helpful to envision apparel products as
solution. This is best accomplished through existing at some point along an aesthetic to
four major thrusts. The first two, materials functional continuum (Figure 1) where the
analysis and design analysis, initiate the location along the continuum reflects the
process in a manner consistent with that balance of requirements. Examples of three
described by Watkins (1995). The latter two
thrusts, design development and evaluation, Figure 1: Aesthetic - Functional Continuum
g
move in the direction of the design solution.
This paper will focus on the design analysis
component of the functional design process
using a surgical gown case study to
illustrate.
Evening gown
Business suit
It seems appropriate to preface discussion of Surgical gown

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common products clarify the continuum. Table 1: Medical Textile Market
Note that those items considered to be Potential Actual
functional apparel, such as a surgical gown, Market Market
have requirements dominated by North $3.4 Billion $1.3 Billion
performance needs and are located near the America
functional end of the continuum.
Europe $3.9 Billion $1.3 Billion
FUNCTIONAL APPAREL 3rd World $3.9 Billion $ 260 Million
Creating a functional apparel
product that addresses all relevant SURGICAL GOWN BACKGROUND
requirements is a complicated undertaking In the early 1900s the first surgical
that necessitates objectifying the design gowns were introduced as 2 sterilized pieces
process (Orlando, 1979). Orlando’s process of lightweight fabric (Belkin, 1998). These
was also utilized successfully by Tan, garments reached the floor and had elbow
Crown and Capjack (1998) in developing length sleeves. They were worn with neither
functional apparel. A similar process was gloves nor masks. In the 1920s, gowns
described by Rosenblad-Wallin (1985). began to be constructed of muslin, which
Watkins (1995) described the stages in a was viewed as a barrier material. In 1939,
functional design process a little differently. concerns were raised about the evident fluid
Unlike the other methods, Watkins’ penetration with muslin. So, rubber was
approach emphasized analysis as the initial applied to increase the barrier and sleeves
stage of the design process. Initiating the were extended to ¾ length. Although
design process via analysis allows for protective, such gowns were considered
effective requirements capture and uncomfortable (Belkin, 1993).
comprehensive understanding of the design
problem, in turn providing a strong
foundation for functional apparel design. Figure 2: Modern Surgical Apparel

THE CASE OF SURGICAL GOWNS

MEDICAL TEXTILES
In August 2001, it was estimated
that sales of medical textiles equaled
approximately seven billion dollars
(Lickfield, 2001). The market has gotten its
biggest boost from advancements in
nonwovens. Kimberly-Clark has leveraged
their nonwoven technologies, such as
Spunbond Meltblown Spunbond technology,
capture 30% of the market in 2001. Du Pont
holds the second position with its Sontara
non-bond spunlace nonwoven composed of
short staple fibers (Lickfield, 2001). Even
so, sales of medical textiles are not meeting
market potential (Table 1). This represents
an opportunity for new medical textile
products.

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During the 1950’s, not only were surgical Surgical gowns must repel diseases and
gown fabrications evaluated, new designs infections yet provide adequate freedom to
were explored. The notion that patients move. They must allow necessary mobility
were a threat to surgeons, along with without rubbing and chafing, and must resist
development of innovative fabrics, drove tearing and linting. They must fit closely but
evolution in gown design. Nonwovens were not restrict movement. Since there is
introduced in different grades and weights generally excess fabric, the gowns must
leading to development of a range of gown withstand constant pulls on the fabric during
types for different levels of protection routine movements. These gowns must be
(Lickfield, 2001). Today, different gowns designed to fit a diversity of body shapes
are designed to handle different surgeries. and sizes with a limited range of sizes as
The cost of gowns varies with the amount of hospitals will only stock limited quantities
protection afforded. To perform a surgery (du Pont, 2001). The gowns must control the
with several risks and a high blood count, a bacteria released into the theater and aid in
higher barrier, and frequently reusable, maintaining the sterile zone required for
gown will be chosen. For less risky patient safety. They must provide for easy
surgeries, a lower barrier disposable gown is donning and doffing without contamination,
used (Stanley, 1994). Disposable gowns yet not have openings where the barrier
offer benefits in that hospitals can dispose of might be breached. Gowns must be durable
the contaminated textiles quickly, they enough to last the intended useful life of the
reduce laundry costs, and they can be garment, be that single or multi-use. They
donned and doffed quickly in locations such should repel fluids but ventilate the surgeons
as Emergency Rooms (Lickfield, 2001). extreme body heat (Belkin, 1993). And all
Nonwoven disposables are not as heavy as of this must be accomplished in a cost-
reusables, and are in turn cooler (Stanley, effective manner (Love, 1987; Slater, 1998;
1994). Zerrath, 1987).

In 1991, the Occupational Safety & Since 2/3 of the production cost for
Health Administration (OSHA) surgical gowns is in the fabric, effective
implemented the Final Rule requiring that fabric utilization is essential. And, like other
all health care workers be protected from apparel segments, garment production costs
blood born pathogens at the expense of the must be carefully controlled.
medical facility (Lickfield, 2001). Though
protection is of critical importance, surgeons DESIGN ANALYSIS
are still unwilling to sacrifice comfort and fit Design analysis involves study of
(Belkin, 1993; Stanley, 1994). Gowns of the end use, and of existing products.
proper fit more effectively repel dangerous Although the literature clarifies many of the
infections and fluids providing improved performance requirements, the strengths and
protection for both medical personnel and limitations of existing products must also be
the patient (Stanley, 1994). understood in order to create superior, or
even revolutionary, new products. Design
PERFORMANCE REQUIREMENTS analysis provides an understanding of
Surgical gowns are worn by doctors existing products. Four strategies are
and nurses in the operating theater to employed in analyzing existing garment
address a dual function of preventing designs: structural analysis, sizing analysis,
transfer of microorganisms and body fluids fabric utilization assessment and fit
from the operating staff to the patient, and evaluation.
also from patient to staff (Slater, 1998).
Many of the performance requirements for Design analysis included thirteen
surgical gowns are well documented. disposable gowns and two reusable gowns
(Figure 3). The reusable gowns were
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included to gain a more complete Table 2. Gowns Used in Analysis
understanding of the products on the market.
In general these gowns are constructed of Manuf. Composition Uses
heavier, more impermeable materials. The
lack of permeability and ventilation tends to Johnson & HDPE Disposable
create a warmer microclimate within the Johnson
gown than that associated with disposable Kimberly- SMS Disposable
gowns. Table 2 lists the gowns included in Clark
the analysis. Kimberly- SMS Disposable
Clark
STRUCTURAL ANALYSIS Kimberly- SMS Disposable
Structural analysis is undertaken to Clark
assess the design features of existing Kimberly- SMS w/ film Disposable
products and to characterize the market. For Clark
surgical gowns, comfort issues related to Kimberly- Film reinforced Disposable
product design were of particular concern as Clark SMS
Figure 3:Compel (left) and Gore-Tex Allegiance woodpulp/ Disposable
(right) reusable gowns polyester
spunlace
Allegiance woodpulp/ Disposable
polyester
spunlace
Allegiance woodpulp/ Disposable
polyester
spunlace
Allegiance woodpulp/ Disposable
polyester
spunlace
Allegiance SMS Disposable
Converter polypropylene
Kimberly- spunbonded Disposable
comfort is a critical product requirement. Clark polypropylene
Although comfort is somewhat dependent Compel 100% polyester Reusable
on the permeability and flexibility of the multifilaments
fabric, there is a design influence (T-PACC, Gore-Tex 100% polyester Reusable
1997). with Gore
Allegiance Breathable Disposable
General construction Impervious
Most of the gowns examined were The back was composed of two overlapping
constructed from 3 to 5 major pieces. panels providing access for donning and
Although many of the gowns had no seams doffing. Ties, used in various locations to
at the side, they had front and back panels secure the gowns, were typically nonwoven
defined clearly by the sleeve placement. The strips similar to the material used to
fronts of the gowns were continuous with no construct the gown.
seams or breaks in the fabric surface. This is
extremely important as the front of the torso Though most gowns featured
is a critical area for barrier performance straight hems, the back panels of one
(Lickfield, 2001). Kimberly-Clark gown angled upward from
each side. This feature was designed to
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provide improved heat release and about 20” below the back neck in the center
ventilation for the surgeons and nurses. back.

Figure 4: MicroCool Specialty Gown The necklines of the gowns were

closed in a variety of ways, all providing
some adjustability for fit. Snaps provided
one means of closing the gown neckline.
The right back panel contained two male
snap components. The female components
were found near the neckline of the left back
panel. Snap components were arranged 1 –
1.5 inches apart to provide four adjustment
Figure 5: Snap closure

Most of the gowns were partially assembled

using traditional stitches and seams,
commonly a 401 double thread chain stitch
with a simple superimposed seam.
Exceptions to this generalization included an choices and flexibility in the fit. Closer
Allegiance gown and the Compel reusable spacing of the snaps enables more accurate
gown that were assembled using a lapped fitting of the neckline region. Snap neckline
seam structure and two parallel rows of 401 closures were found on several Kimberly-
stitching. A large stitch length was used to Clark gowns and also on the Compel
minimize puncturing of the fabric and limit reusable gown.
interference with the barrier performance. Hook and loop tape closures were also used
Sleeve seams, critical zones for barrier to secure some of the sample gowns. The
performance, were typically fused. For loop component of the tape was placed at
improved barrier performance at the seams, the neckline of the left back panel. The
one Kimberly-Clark gown was entirely corresponding hook component was found
fused at the seams. on the right back panel. The hook
component is about 1.5” long, and the loop
Closures component 7” long providing great
To close the body of the gowns, flexibility and accuracy in the neckline fit.
mechanisms were attached to the right and This closure was found on the Allegiance
left back panels. The right back panel had an samples. An alternative to the hook and loop
internal tie attached approximately 20” tape, is an adhesive tape similar to that
down from the shoulder. It also had an found on disposable diapers. On the right
external tie attached about 20” from center back panel, a tab of tape was attached. After
back. The corresponding tie was on the the backing is removed, the tape can be
front panel, located about 20” from the affixed to any location on the left back
shoulder. Several of the gowns had a fused neckline. Tape closures were used on a
reinforcing tape placed over the location Johnson & Johnson gown, and a Kimberly-
where the exterior tie was stitched onto the Clark gown. Hook and loop closures and
front panel for added strength and to restore tape closures provide great ease, accuracy
the compromised barrier. The left back and flexibility in fit, but often elicit
panel had a tie located on the outside usually complaints from surgical personal due to
easy entanglement of hair in the closure.
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 Kimberly Clark gown used a band of rubber
attached to the outside of the sleeve at the
Figure 6: Hook and loop closure wrist. The sleeve is pleated before fusing on
the band creating folds rather than the more
bulky gathers.

SIZING ANALYSIS
The designs of disposable gowns
allow them to accommodate several body
types and sizes, but they are generally too
big. Additionally, medical institutions tend
to order L-2XL sizes for the whole staff (du
Pont, 2002). Reusable gowns have a fit that
Figure 7: Tie closure
is more true to size with easier to adjust
necklines and closer fit in the torso.
Measurements were taken on the
surgical gowns to form a sizing analysis.
Not all gowns utilize the same sizing
system, so the size most commonly stocked
by hospitals was used. Prior to completing
measurements, the gowns were tied closed,
and were then laid flat on a table.
Measurements were taken at:
Closures featuring a pair of ties may • Front Panel,
be used to secure neckline, as in the Gore- • Back Panels,
Tex reusable gown. The right back panel • Sleeves,
includes a tie at the neckline edge and • Cuffs,
another inside the neckline near the • Tying Closures,
shoulder. The corresponding ties are located • Circumferences
outside of the left back panel near the A database was created to facilitate
shoulder and at the edge, respectively. later analysis of the gown measurements.
Sleeves/cuffs Table 3 summarizes the largest, the smallest,
A majority of the sleeves on the and average measurements among the
gowns were a raglan style. Although this gowns.
style is often perceived to provide superior
ease of movement, it can provide so much MATERIAL UTILIZATION ANALYSIS
bulk and excess fabric that comfortable As mentioned previously, material
movement is inhibited. Two Kimberly Clark cost can be 2/3 of the total cost of
gowns had set in sleeves, limiting excess manufacturing a gown (du Pont, 2002). A
fabric in the shoulder and upper chest area. material utilization analysis was performed
Excess fabric in this area, as well as excess to determine the amount of fabric needed to
sleeve length and width, inhibits mobility in cut the components of each gown. Unlike
reaching, especially reaching over an woven or knitted fabrics, the nonwoven
obstacle, such as a patient in surgery. materials used in disposable gowns can be
ordered from the vendor in any desired
The sleeve edges were contained width. Gown manufacturers often order two
with a cuff stitched on at the wrist. In use, different fabric widths, one for the sleeves
surgical gloves are worn pulled up over the and one for the body of the gown, in order to
cuffs, so it is important for the cuffs to fit minimize fabric waste. Hence, utilization is
snugly. All of the gowns except one from
Kimberly Clark used a rib knit cuff. The
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commonly expressed in square yards for stored in a database. The fabric
comparison. requirements ranged from 2.53 to 5.66
To conduct the analysis, all of the square yards and averaged 3.12 square
disposable gowns were taken apart at the yards. Most of the gowns also required
seams and the pieces laid out, gown by an average of 30 inches of a 2.5to 3.5
gown, on a table. The fabric requirement inch wide tubular rib knit for the cuffs.
for each gown was determined and

Table 3: Selected gown dimensions

Location Smallest Largest Average
Measurements Measurements Measurements
Inches Inches Inches

Sleeve Width Biceps 9.5 10 9.75

Cuff Length 3 3.25 3.13
Width 2 3 2.50
Sleeve Length Neckline to Cuff 30 36.5 32.80
Underarm to Cuff 20.25 25 22.63
Front Panel Length 41.5 54.5 48.00
Side Seam to Side 22.25 48 35.13
Seam
Side Seam Length 36 43.25 39.63
Circumference Total Bottom 60.75 69 64.88
Back Right Panel 15.5 25 20.25
Bottom
Back Left Panel 13.75 18 15.88
Bottom
Center Back Length 20.5 53 36.75
Right Back Underarm Width 15.5 22.5 19.00
Inside Tie Length 17 20 18.50
From Shoulder
Inside Tie Diagonal 18 9 13.50
From Underarm
Outside Tie Length 17.25 21 19.13
from Neck
Left Back Underarm Width 13.5 16.5 15.00

FIT ANALYSIS TESTING

To evaluate the fit of the gowns, an analysis fit. For each gown, participants evaluated
strategy was devised. For the evaluation, the fit first while standing in a relaxed
participants tried on each of the 15 gowns posture, and then following performance of
and both objective and subjective measures a minimal range of motions that mimicked
of fit were obtained. Selected physical those of operating room personnel.
measurements provided an objective
measure of fit. Evaluations completed by Physical measurements
participants provided subjective measures of
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Participants were assisted in donning and walking, a series of arm movements and
closing each gown properly prior to reaches, and two bending/stretching
evaluation. Then, to provide an objective motions.
appraisal of fit, excess fabric was measured
and recorded using a measuring tape. Two evaluation instruments were used to
record participants’ evaluations. Each gown
Figure 8: Measurement location required completion of a separate set of
instruments. Instrument I consisted of
Shoulder
general questions. The questions related to
Sleeve the comfort, fit, and restriction level of the
Width gowns. This instrument was filled out three
Waist times for each gown, first for rating period
one (standing), then for rating period two
(activities), and finally subjects provided an
overall rating. Figure 9 is the item from
Instrument I that was used for rating gown
Sleeve restrictiveness. Similar items were provided
Length
for rating fit and comfort.
Comments:
Bottom
Distance Instrument II was designed to obtain
detailed information on gown fit (Figure
10). For each gown, the subjects filled out
the instrument for rating period one
(standing) and again for rating period two
(activities). Five choices of terms were
Measurements included (Figure 8):
available to describe how the garment felt
• Excess sleeve length and width
for each time period. For comparison,
• Distance between the gown and the averages were determined for each rating on
floor with arms at side and with arms each item.
raised
• Excess fabric in the shoulder area CONCLUSION
• Excess fabric at the waist The data accumulated in the design analysis
of existing products provides a firm
Subjective evaluation foundation for undertaking product redesign.
Evaluation instruments were developed The next step in the design process is to
based on past research (T-PACC, 1999) and examine the data for relationships between
literature review. Videotapes of medical structure, measurements, and fit evaluations.
procedures were also used to determine an Each learning from the analysis helps to
appropriate range of motions to include in define product requirements and informs the
the evaluation. Movements by medical design and development process.
personnel are not permitted to extend
beyond a limited sterile zone during surgery. ACKNOWLEDGEMENTS
So, selected activities included a limited The authors would like to thank E. I. du
range of motions expected during surgery or Pont de Nemours and Company for their
in moving from a dressing area into the support of this research. They would also
operating theater. The activities were like to gratefully acknowledge the
performed while attired in each gown. A contributions of Diana Razulis in assisting
pilot test was used to fine-tune each activity with data collection.
and to determine the time required to
complete the procedure. Activities included

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 Figure 9: Gown Restrictiveness Rating Item from Rating Instrument I
RATING PERIOD 1 2 Overall

RATING

1. Very Restrictive 5. Slightly giving

2. Restrictive 6. Giving
3. Slightly restrictive 7. Very giving
4. Neither restrictive/giving

Figure 10: Gown Rating Instrument II

Totally Mostly Mildly Partially Not at all
1. Stiff gown (no drape)
2. Loose neckline
3. Tight neck (cuts throat)
4. Tight at top shoulder
5. Tight armhole
6. Sleeve is too long
7. Sleeve is too short
8. Tight sleeve cuff
9. Bulky bunched material
10. No stretch
11. Long: pulls in the front
12. Nonconforming

Love, E. (ed.) (1987),

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du Pont de Nemours and Company. T-PACC. (1999), Surgical gown

(2002). Personal communication with a wear trials, Textile Protection and Comfort
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Lickfield, D. (2001, Aug.), “Non- Orlando, J. (1979), “Objectifying

Wovens in Medical Textiles”, International apparel design”, Combined Proceedings,
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Author Information
Traci May-Plumlee
Department of Textile and Apparel,
Technology and Management
North Carolina State University
Email: [email protected]

Amanda Pittman
Department of Textile and Apparel,
Technology and Management
North Carolina State University
Email: [email protected]

Article Designation: Scholarly 10 JTATM

Volume 2, Issue 2, Spring 2002