Orbit

The International Journal on Orbital Disorders, Oculoplastic and

Lacrimal Surgery

ISSN: 0167-6830 (Print) 1744-5108 (Online) Journal homepage: https://www.tandfonline.com/loi/iorb20

How Do Absorbable Sutures Absorb? A Prospective

Double-Blind Randomized Clinical Study of Tissue
Reaction to Polyglactin 910 Sutures in Human Skin

Barry T. Cartmill, David M. Parham, Paul W. Strike, Liz Griffiths & Ben Parkin

To cite this article: Barry T. Cartmill, David M. Parham, Paul W. Strike, Liz Griffiths & Ben Parkin
(2014) How Do Absorbable Sutures Absorb? A Prospective Double-Blind Randomized Clinical
Study of Tissue Reaction to Polyglactin 910 Sutures in Human Skin, Orbit, 33:6, 437-443, DOI:
10.3109/01676830.2014.950285

To link to this article: https://doi.org/10.3109/01676830.2014.950285

Published online: 22 Sep 2014.

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Orbit, 2014; 33(6): 437–443
! Informa Healthcare USA, Inc.
ISSN: 0167-6830 print / 1744-5108 online
DOI: 10.3109/01676830.2014.950285

ORIGINAL ARTICLE

How Do Absorbable Sutures Absorb? A Prospective

Double-Blind Randomized Clinical Study of Tissue
Reaction to Polyglactin 910 Sutures in Human Skin
Barry T. Cartmill1, David M. Parham1, Paul W. Strike2, Liz Griffiths1, and Ben Parkin1

1
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom and 2Salisbury NHS Foundation Trust,
Wiltshire, United Kingdom

ABSTRACT
Objective: To compare the tissue reaction produced by 2 gauges of implanted polyglactin 910(Vicryl) suture
material in human skin.
Methods: A prospective, double masked, parallel randomized IRB approved clinical trial. Consecutive patients
with involutional entropion and horizontal eyelid laxity were randomly allocated to 5/0 or 7/0 gauge test
suture groups. Symptoms were alleviated during the wait for definitive surgery by placement of eyelid everting
sutures. After 28 days, surgical entropion correction including eyelid wedge excision was achieved. Histological
analysis was carried out, masked to the suture gauge used, on the excised eyelid containing one of the
temporary everting sutures. Both patient and analyst were masked to the suture group. The four primary
outcome measurements were granuloma outer diameter, central cellular diameter, giant cell number and area of
fibrous coat and a statistical comparison made between suture gauge groups.
Results: 21 patients were allocated to each group, and histological analysis was possible in 36 patients.
Significant suture-related granulomatous inflammatory reactions were found in all specimens. Medians of the
measurements for 5/0 and 7/0 gauge sutures, respectively, were 0.855 mm versus 0.387 mm granuloma outer
diameter (p = 0.0001); 0.464 mm versus 0.250 mm central cellular element diameter (p = 0.0003); 0.194 mm2 versus
0.053 mm2 fibrous coat area (p = 0.0009) and 0.8 versus 1.2 giant cell number (p = 0.7511).
Conclusions: Polyglycolic acid sutures elicit a significant foreign body inflammatory response proportional to
suture gauge. This reaction may be minimized by early suture removal. The study validates a novel and ethical
approach to the examination of human skin response to implanted suture material.
Keywords: Human polyglactin response, polyglactin-induced scarring, polyglactin tissue reaction,
stitch granuloma, suture granuloma

INTRODUCTION obtained opportunistically following surgical compli-

Despite the importance of cutaneous scars and wound
healing to surgeons, ethical considerations have pre-
vented the prospective study of the normal
unwounded human cutaneous tissue reaction to
implanted suture material. The histological reaction
of oral mucosa to sutures following surgery has been
investigated using biopsy,1–4 or explanted suture
material.5 Other histology specimens have been
cations,6–8 or following revision surgery.9 However,
these data may not be applicable to human cutaneous
tissue which has not been subjected to surgery.
The majority of absorbable sutures are based on
polyglactin 910 (PCA), which is readily broken down
by hydrolysis in the laboratory. However, adverse
clinical reactions to implanted suture material includ-
ing inflammation and granulomas are regularly
observed.10–12 Such reactions may have serious

Received 10 November 2013; Accepted 28 July 2014; Published online 22 September 2014
Correspondence: Dr. Barry T Cartmill, Clinical Fellow in Oculoplastic Surgery, Royal Bournemouth Hospital, Castle Lane East, Bournemouth,
Dorset BH7 7DW, United Kingdom, Tel: 02871345171. E-mail: barrycartmill@hotmail.com

437
438 B. T. Cartmill et al.
adverse effects on scarring and functional outcome,
particularly in facial and periocular surgery.
Lower eyelid entropion is a common eyelid
malposition typically affecting older patients.
A delay before definitive surgical correction is
normal in most centres due to high demand.
Symptoms may be controlled in the meantime by
temporary everting sutures to reposition the eyelid.
An important predisposing risk factor for the devel-
opment of entropion is eyelid laxity, and surgical
management involves reduction of this laxity through
eyelid shortening. The Quickert procedure is long
established as effective in the correction of entropion
and includes the excision of a wedge of the affected
eyelid.13 If this eyelid wedge includes implanted
suture material (previously placed for temporary
relief of symptoms) a unique ethical opportunity for
the study of human tissue reaction to implanted
materials is created.
The authors hypothesize that cutaneous sutures
generate a significant inflammatory reaction during
hydrolysis proportional to the suture gauge. This
paper reports the results of the first known prospect-
ive, double blind study investigating the histological
reaction of normal unwounded human cutaneous
tissue to PCA suture and a comparison of the reaction
elicited by 5/0 and 7/0 gauge sutures.
MATERIALS AND METHODS
The study design was a prospective, randomized,
parallel double-masked clinical study. A favourable
opinion was obtained from the regional Research
Ethics Committee and NHS permission was obtained
from the Trust Research Lead. The research adhered
to the tenets of the Declaration of Helsinki and the
trial has been registered (Identifier NCT01598376,
www.clinicaltrials.gov). Literature review was based
on a medline database search from the period 1954 to
2012 limited to the English language using the
following keywords in various combinations: suture,
tissue reaction, granuloma, polyglycolic acid, polyglactin,
inflammation, histology, and human.
Standard care for involutional entropion in our
department where immediate surgical management is
not possible is to offer patients temporary eyelid
everting sutures for relief of symptoms. These sutures
are removed at the time of definitive surgery.
Consecutive male and female individuals aged
over 18 years referred to an oculoplastics clinic with
involutional entropion and significant horizontal lid
laxity were eligible for inclusion in the study.
Exclusion criteria included a history of previous
eyelid surgery, a systemic illness likely to influence
tissue healing response (i.e. uncontrolled diabetes,
concurrent steroid use or Addison’s disease) or
inability to provide informed consent. A full detailed
oral and written explanation of the study was given
by the clinician. It was specifically emphasized
that everting sutures alone may be an effective
treatment for entropion in some patients.14
Participants were advised that the long term recur-
rence rate following entropion surgery without eyelid
tightening is high.15
Once informed consent had been obtained, clin-
icians contacted the research office and provided the
date of birth and participant initials prior to allocation
of a study ID number. Research data were recorded on
a report form identified by ID number to ensure
anonymity and confidentiality. Participants were
assigned to blocks by sex and age (above or below
75 years) prior to randomization. One eyelid from
each patient was randomised to either 5/0 (0.1 mm
diameter) or 7/0 gauge (0.05 mm diameter) PCA
braided suture if a random number (generated
between 0 and 1 by the RAND function in Excel)
was greater or less than 0.5 respectively. Histological
parameters were measured in a separate department
by a single clinician masked to the suture gauge used.
The suture gauge group was identified for statistical
analysis once recruitment and measurements were
complete.
All study patients were masked to their suture
group and underwent insertion of temporary eyelid
eversion sutures in the minor operations theatre
without delay once informed consent was obtained.
Definitive surgery was carried out 28 days later.
SURGICAL TECHNIQUE
The lower eyelid was anaesthetised with 1–2 mL of
0.5% bupivacaine with 1:200,000 adrenaline injected
subconjunctivally. Two double armed 6/0 PCA eyelid
everting sutures were placed medially and centrally.
The third everting suture was treated as the test
suture (5/0 or 7/0 gauge PCA) and was placed to
emerge in the lower lid 15 mm from the lateral
canthus. After 28 days, participants underwent a
modified Quickert procedure.13 Briefly, following
anaesthesia as above, a full thickness eyelid wedge
containing the lateral test suture was removed and
placed in formalin. A transverse eyelid split was
made below the level of the tarsus and three 6/0 PCA
everting sutures placed. The eyelid wedge was
paraffin processed and stained with haematoxylin
and eosin (H&E) for histological analysis.
HISTOLOGICAL ANALYSIS
Histological examination was carried out in a separate
department by a single clinician masked to the test
suture gauge. For all parameters, the minimum
diameters were measured to reduce errors from
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oblique angle sectioning of the granuloma.
A 3D optical scanner (OPT scanner 30001 M,
Bioptonics, MRC Technology, Edinburgh, UK) identi-
fied the location of suture in the wedge specimens
prior to sectioning (Figure 1).
Any suture associated granuloma was identified
(Figure 2) and the four primary outcome measures
(outer diameter, central cellular element diameter,
fibrous coat diameter (FD) and thickness (FT) and
FIGURE 1. Photomicrograph of an eyelid excision specimen,
3D optical scanner (OPT scanner 30001M, Bioptonics, MRC
Technology, Edinburgh, UK), magnification 7. The implanted
suture is clearly visible just below the skin in this wedge of
lower eyelid. Eye lashes are seen above, with meibomian ducts
visible as grey columns behind.
FIGURE 2. Eyelid wedge specimen showing a typical
granuloma (haematoxylin-eosin, original magnification, 40).
The suture fibrils are clearly visible as refractile bodies within
the central cellular element surrounded by a fibrous coat.
Multiple foreign body giant cells are present. GD granuloma
diameter, C central cellular element diameter, GC giant cell,
F fibrous coat.
! 2014 Informa Healthcare USA, Inc.
Tissue Reaction to Absorbable Sutures 439
giant cell number) were measured at a mean of 6
different levels. The medians were calculated for each
index. The area of fibrous tissue in each granuloma
cross-section was calculated by subtracting the area of
the central cellular element from the area of the
fibrous coat. As area = (d/2)2 the fibrous coat
area = (FD/2)2 ([FD FT]/2)2.
STATISTICAL ANALYSIS
Professional statistical advice was sought. The authors
found no published data on cutaneous tissue response
to different suture gauge in human patients and
limited data are available from animal models to
inform statistical power calculations. A study in rats
has shown that suture gauge is a significant inde-
pendent factor in the determination of tissue reaction
and a similar effect could be expected in human
subjects.16 The individual outcome measures are all
highly dependent on the degree of inflammatory
response. For these reasons, the study was powered to
seek evidence of a standardised treatment effect size
of 1 or more, on each of the four treatment outcome
variables (assuming inter-correlations of around 0.5),
with test Power 0.8 and a global test Alpha-error rate
of 0.05. Using a correlation corrected Bonferroni
adjustment for multiple-testing, we required 21 test
subjects in each treatment group using a test signifi-
cance level of 0.025 throughout. All calculations
undertaken using nQuery Advisor v.5 (Statistical
Solutions Ltd, Ireland).
All outcome distributions exhibited a right-tail
skew (see Figure 3). Granuloma measurements
were therefore compared (according to the suture
gauge originally assigned) using the non-parametric
Mann-Whitney test (StatXact v.6, Cytel Software
Corp).
RESULTS
From June 2010 to March 2011 a total of 47 consecutive
patients were considered for inclusion in the study
and 42 were enrolled as detailed in the flow chart
(Figure 4). All these patients went on to have
definitive surgery including removal of the original
everting sutures after 28 days as defined in the study
protocol (mean 28 days, SD 1.5 days). One patient in
the 5/0 suture group developed a large suture
granuloma and chose to leave the study prior to
definitive surgery. No analysis was possible in 5 of the
remaining 41 patients (3 in the 5/0 group and 2 in the
7/0 group).
In 2 cases the suture was neither visible on 3D
scanning nor in any serial histological section, and
was assumed to have fallen out. In another 2 cases the
suture material was enclosed by surface epithelium
440 B. T. Cartmill et al.
FIGURE 3. Graphs showing the distribution of measurements for granuloma diameter (mm), central cellular element diameter (mm),
giant cell count and fibrous coat area (mm2) in 5/0 and 7/0 suture groups (horizontals display medians, boxes, 50% data
spread, whiskers, 95% data spread and asterisks, outliers of more than 99% spread). p values less than 0.001 highly statistically
significant, after correlation corrected Bonferroni adjustment for multiple testing.
along its full length (serial sections) without
granuloma formation. In 1 case, the suture was
knotted in the specimen preventing meaningful
measurement. Histological analysis was carried out
on the remaining 36 patients, 17 with 5/0 PCA and
19 with 7/0 PCA test sutures. There were no statis-
tically significant age (p = 0.930) or sex (p = 0.671)
differences between these two groups. The study
was terminated once sufficient participants in each
group had been recruited.
All sutures were associated with a typical foreign
body granuloma consisting of an epithelioid cell
infiltrate with variable numbers of multinucleate
giant cells and polymorphonuclear leucocytes sur-
rounded by a coat of fibroblasts (Figure 2). Statistical
results are summarised in Figure 3. The median
diameter of the suture granuloma was strongly
dependent on suture gauge (0.855 mm versus
0.387 mm for the 5/0 and 7/0 suture respectively;
p = 0.0001, 95% CI 0.20 to 0.57, Cohen’s treatment
Effect Size (ES) = 1.66). The median diameter of the
central cellular element was similarly dependent
(0.464 mm versus 0.250 mm; p = 0.0003, 95% CI 0.12
to 0.34, ES = 1.47).
In these indices, the larger suture gauge resulted
in an approximate doubling of the diameter of
inflammatory infiltrate. The area of fibrous coat was
even more strongly dependent with 5/0 gauge suture
resulting in approximately 4 times more fibrous
tissue in cross section (medians 0.194 mm2 versus
0.053 mm2; p = 0.0009, 95% CI 0.04 to 0.22, ES = 1.29)
than 7/0 gauge suture. The giant cell count was
highly variable and the suture gauge did not have a
statistically significant effect (0.8 cells versus 1.2 cells
for the 5/0 and 7/0 gauge suture respectively;
p = 0.7511, 95% CI 0.95 to 1.26, ES 0.11).
DISCUSSION
Cutaneous scarring is an extremely important issue
in facial plastic, reconstructive and aesthetic
surgery. In the periocular area scarring may addition-
ally interfere with eyelid function. Although tissue
adhesives are occasionally used,17,18 sutures are
the standard method for closing facial surgical
wounds and suture choice is an important factor
influencing the scarring process. Suture properties
such as material, filament type, coating and
gauge all affect the tissue reaction and final
scar. Although there is extensive scientific literature
on the cutaneous tissue reaction to sutures in animal
models, as far as the authors are aware, there has been
no prospective study in normal human cutaneous
tissue.
Polyglycolic acid (PCA) is a tough, fibre-forming
polymer and has been used to produce synthetic
absorbable sutures since the early 1960s. VicrylTM
has become a highly popular braided coated PCA
suture worldwide and is extensively used in
oculoplastic surgery. When exposed to physiological
conditions, PCA is degraded by random hydrolysis
and esterase activity into glycolic acid. This can then
be excreted in urine or enter the tricarboxylic
acid cycle to form water and carbon dioxide.19
A simple tissue hydrolytic reaction would not be
expected to stimulate significant inflammation and
promotional literature is consistent with this assertion.
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Assessed for eligibility (n=47)
Enrolment
Randomised (n=42)
Allocation
Allocated to 5/0 suture gauge (n=21, 13M, 8F):
Received allocated intervention (n=21)
Did not receive intervention (n=0)
Lost to follow-up (n=0)
Follow-up
Left study (n=1)
developed suture granuloma and
chose to leave study
Analysed (n=17):
Excluded from analysis (n=3)
1) A female with no measurable sections
Analysis
despite 24 histological levels (all sutures were
the skin surface or deep in an epithelial cleft)
2) A female with suture enclosed by surface
epithelium along its full length without
granuloma formation
3) A male where the only suture was caught
at a turning point (a knot) and could not be
measured despite 16 histological levels
FIGURE 4. Flow chart summarising participant flow, numbers, randomization assignments, interventions and completeness of
follow-up. Reasons for loss to follow-up detailed.
e.g. ‘‘[PCA suture] absorbs by hydrolysis in 60 to
90 days with virtually no tissue reaction.’’20
‘‘Coated VICRYL sutures elicit only a mild tissue
reaction during absorption.’’21 However, suture-
associated inflammation and granuloma are well
recognised in postoperative patients.10–12
Investigation into cutaneous suture-induced tissue
reaction has been performed in animal models,
particularly the rat and rabbit.22–25 Initially, the
foreign surface is thought to be covered with matrix
metalloproteinases (MMPs), MMP1 and MMP2.26
Subsequent denaturation and absorption of these
proteins causes recruitment of circulating monocytes
and local macrophages which form a dense infiltrate
around the foreign body. The release of inflammatory
cytokines recruits fibroblasts and results in the
formation of a fibrous capsule around the infiltrate.25
Eventually a mature foreign body granuloma forms.
! 2014 Informa Healthcare USA, Inc.
Tissue Reaction to Absorbable Sutures 441
Excluded (n=5)
Not meeting eligibility criteria (n=3)
Declined to participate (n=2)
Other reasons (n=0)
Allocated to 7/0 suture gauge (n=21, 12M, 9F):
Received allocated intervention (n=21)
Did not receive intervention (n=0)
Lost to follow-up (n=0)
Left study (n=0)
Analysed (n=19):
Excluded from analysis (n=2)
1) A male who had no suture present at any
level despite 20 histological levels
2) A female with suture enclosed by surface
epithelium along its full length without
granuloma formation
This represents a balance between inflammatory and
fibrotic reaction and can lead to extensive scarring if
there is persistent inflammation.27–29 Granuloma size
is closely related to the inflammatory activity and
indicates biocompatibility of the suture material.30.
Prospective studies in human oral mucosa have also
shown significant inflammation,1–5,31 but no prospect-
ive data on the human cutaneous suture reaction have
been published.
The authors have developed a new model which
allows the prospective study of cutaneous tissue
reaction to implanted suture material in patients
presenting with eyelid entropion. Eyelid everting
sutures alone may be used as a temporary measure
for symptomatic relief from entropion by correcting
the lid position. In the presence of significant lid
laxity, this is unlikely to be a permanent cure. In this
model, a test suture is included as one of the three
442 B. T. Cartmill et al.
temporary everting sutures. The Quickert procedure
has long been established as effective in the correction
of involutional entropion.13
There are three aspects to this procedure.
The transverse lid split creates a scar preventing the
upward movement of the preseptal orbicularis and
the everting sutures shorten the lower lid retractors
and transfer their pull to the upper border of the
tarsus. Finally the eyelid wedge resection reduces the
associated eyelid laxity. The histological analysis of
eyelid wedge excision specimens from definitive
surgical procedures containing pre-placed test suture
material may thus be carried out in a prospective
ethical manner. In this study, the difference in tissue
reaction elicited by two different suture gauges has
been examined.
Histological analysis was not possible in 3
patients from the 5/0 group and 2 patients from the
7/0 group. It is most unlikely this data would
have affected the conclusions as the treatment
effect was large and the missing data split between
each group.
Despite eventual degradation by hydrolysis, this
study has confirmed that PCA suture incites a
significant foreign body granulomatous response in
human cutaneous tissue, consistent with animal
studies. The suture gauge and therefore the volume
of suture material, strongly determines the degree of
inflammatory response and the volume of fibrous scar
tissue. It is likely that monofilament sutures will
provoke less tissue response, but further human
studies are required to test this hypothesis.
This study provides scientific evidence supporting
commonly held views guiding absorbable suture
choice. Specifically, the smallest possible suture
gauge should be used for surgical repair. It may be
preferable to use larger gauge buried sutures
in wounds under tension, maximising the fibrotic
element of the scar, at the expense of a vigorous
inflammatory reaction. Importantly, and in contrast to
many surgeons practice, the authors would recom-
mend the removal of PCA sutures as soon as the
wound is sufficiently strong. This will minimise the
granulomatous inflammatory reaction and potentially
improve the final surgical scar.
Finally, the study validates this novel model for the
ethical study of suture-related tissue reaction in
patients. Future studies of other suture materials
and types with more extensive tissue analysis includ-
ing immunohistochemistry are anticipated.
ACKNOWLEDGMENTS
Financial support was provided by The Royal
Bournemouth Hospital. Thanks are expressed to
MRC Technology (Edinburgh) for the loan of the
OPT Scanner.
DECLARATION OF INTEREST
None of the authors have any proprietary/financial
interest to disclose. The authors alone are responsible
for the content and writing of the paper.
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