ANATOMY AND PHYSIOLOGY 1 (2125)

Original Research ajog.org

OBSTETRICS

Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial

Yair Daykan, MD1; Maya Sharon-Weiner, MD1; Yael Pasternak, MD; Keren Tzadikevitch-Geffen, MD; Ofer Markovitch, MD; Rivka Sukenik-Halevy, MD; Tal Biron-Shental, MD

BACKGROUND: The optimal choice of skin closure at cesarean RESULTS: Demographic characteristics, patients’ clinical background,

delivery has not yet been determined.

OBJECTIVE: This study compared wound complications and scar healing following cesarean delivery between 2 methods of skin closure:

glue (Dermabond; Ethicon, Somerville, NJ) and monofilament (Monocryl;

Ethicon) epidermal sutures.

STUDYDESIGN:We conducted a randomized controlled trial in which pregnant women undergoing a scheduled cesarean delivery were

randomly assigned to skin (epidermis) closure with glue or with a mono-

filament synthetic suture. The subcutaneous tissue was sutured for all

patients. Outcome assessors were blinded to group allocation. Scars were

evaluated >8 weeks. Primary outcome measures were Patient and Observer Scar Assessment Scale scores. Secondary outcome measures

were surgeon satisfaction, duration of surgery, duration of hospitalization

after the cesarean delivery, and complications of surgical site infection or

wound disruption (hematoma or seroma). A sample of 104 women was

needed to achieve a clinically significant effect with a power of 80%.

Cite this article as: Daykan Y, Sharon-Weiner M, Pasternak Y, et al. Skin closure at cesarean delivery, glue

vs subcuticular sutures: a randomized controlled trial. Am

J Obstet Gynecol 2017;216:406.e1-5.

0002-9378/$36.00 ª 2017 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2017.01.009

406.e1 American Journal of Obstetrics & Gynecology APRIL 2017

prepregnancy body mass index, and subcutaneous thickness were similar

in both groups. Length of surgery between the groups (37 � 10 minutes for glue vs 39 � 13 minutes for sutures, P ¼ .515) was similar. Scores immediately after the wound closure were similar for both groups

regarding surgeons’ time estimate of closure (P ¼ .181) and closure appearance (P ¼ .082). Surgeons’ satisfaction with the technique was significantly higher in the suture group (P ¼ .003). No significant differ- ences were found between the groups in blood loss, surgical site infection,

length of postpartum hospitalization, or wound disruption. Glue and suture

skin closure scores using Patient and Observer Scar Assessment Scale

were similar 8 weeks after surgery, at P¼ .710 for patients and P¼ .568 for a physician observer.

CONCLUSION: Skin closure using glue or a monofilament synthetic suture had similar results. Both methods were shown to be safe and

successful for skin closure after a scheduled cesarean delivery and,

therefore, can be used based on surgeon and patient preferences.

Introduction Cesarean delivery (CD) rates have increased during the last few decades and it has become the most common surgery during women’s reproductive years.1 However, despite its prevalence, data regarding many aspects of the preferred surgical technique are sparse.

Skin closure is an integral step of CD. It influences postoperative pain, wound healing, cosmetic outcome, and surgeon and patient satisfaction.2

There is currently no definite evidence regarding the best method for skin closure after CD.3-5 Staples have been suggested as inferior to other tech- niques.3 Given the conflicting data available, obstetricians are forced to base their decisions on personal preference.

Dermabond glue (Ethicon Inc, Somer- ville, NJ) is a liquid monomer that forms a strong tissue bond with a protective barrier that adds strength and inhibits bacteria. An in vitro study found that glue inhibits both gram-positive (meth- icillin-resistant Staphylococcus aureus and S epidermidis) and gram-negative (Escherichia coli) bacteria.4 In addition, glue has the potential advantages of rapid application and repair time. It has been shown to achieve cosmetically similar results compared to staples within 12 months of the repair.5,6 Also, glue was shown to be well-accepted by patients.5

To date, there have been no ran- domized controlled trials comparing skin closure with glue to sutures using the Patient and Observer Scar Assess- ment Scale (POSAS). The POSAS is a validated and reliable instrument that is practical for assessing scars.7-9 It is comprehensive and correlates well with patient ratings. Previous studies regarding skin closure

with glue were small, retrospective, and included mixed populations and varying

surgical techniques. Therefore, clear, conclusive recommendations are lacking.

This prospective study compared the outcomes of skin incision wound closure using glue or sutures after a scheduled CD.

Materials and Methods This randomized, controlled trial was conducted in a single, tertiary care medical center over a 6-month period. The study was approved by the local institutional review board and was registered with the clinical trials registry (Clinical-Trials.gov identifier NCT02831946).

Patients were recruited consecutively 1-3 days prior to an elective (prelabor, scheduled) CD during the routine pre- operative assessment. All patients scheduled for an elective CD for various indications who agreed to participate in the study were included and provided signed informed consent.

Inclusion criteria were patients with a routine indication for an elective CD (eg, previous CD, breech presentation), maternal age 18-45 years, previous CD

ajog.org OBSTETRICS Original Research

performed using the Pfannenstiel method, at 37-41 weeks of gestation based on first-trimester ultrasound, and a viable fetus.

Exclusion criteria were an emergency CD, previous CD not using Pfannenstiel method, clinical signs of infection at the time of CD, uncontrolled diabetes mel- litus (defined as Hemoglobin A1c> 6%, unbalanced daily glucose measurements, and fasting glucose >95 mg/dL), history of keloids, known hypersensitivity to any of the suture materials used in the pro- tocol, or any disorders requiring chronic corticosteroids or immune suppressants.

Participants were randomized for skin closure with glue or sutures prior to surgery using designated software (Randomizer for clinical trial, iOS app version 2.0; Medsharing, Paris, France). Prophylactic cephalosporin was admin- istered to all patients within 60 minutes before skin incision, based on American Congress of Obstetricians and Gynecol- ogists recommendations.10

Scars fromprevious CDwere removed at the beginning of the surgery. The same incision site was used for the current CD. The skin and dermis were opened using a sharp technique with scissors and with coagulation when indicated. In both groups after closure of the rectus fascia, the subcutaneous fat layer was closed with 3-4 interrupted, coated Vicryl plus antibacterial 2-0 sutures using a V 26 needle (coated polyglactin 910 suture with triclosan; Ethicon, Somerville, NJ). In the glue group, we used 2 layers of Dermabond to close the outer skin layer. Based on manufacturer’s recommenda- tions, the first layer of glue was applied to attach the skin edges. Sixty seconds later, a second layer was added to improve the strength of the adhesion and to create a barrier intended to decrease wound infections.

Dermabond is a liquid monomeric (2-octyl cyanoacrylate) formulation that undergoes an exothermic reaction upon exposure to moisture, changing to polymers that form a strong tissue bond. The wound was not dressed with an abdominal pad or adhesive tape ac- cording to manufacturer’s instructions. In the suture group, the skin was closed with Monocryl (poliglecaprone) 3-0

placed under the skin using a blind su- ture technique. Steri-Strips (3MCorp, St Paul, MN) were used to cover the wound according to manufacturer’s instructions. They were placed vertically along the entire incision. Five surgeons participated in the

study. We evaluated their satisfaction with each closure method (glue vs sutures) based on 3 questions asked immediately upon completion of sur- gery: (1) How comfortable were you with the technique? (not at all [1] to totally comfortable [5]); (2) Was the estimated total operating time longer using glue/sutures compared to skin closure with staples? (not at all [1] to yes, a lot longer [5]); and (3) Were you satisfied with the final closure appear- ance? (not at all [1] to yes, very satisfied [5]). The surgeons did not participate in the recruitment process. They operated using glue or sutures according to the patient randomization schedule. The appearance of the scars was

evaluated 8 weeks after the CD by both the patient and a physician, who was blind to the technique used for skin closure. For scar evaluation, we used a validated scale: POSAS.7-9

The Observer Scar Assessment Scale rates 5 variables: vascularity, pigmenta- tion, thickness, relief, and pliability. Each variable is ranked from 1-10, with 1 rep- resenting normal skin. Ratings are sum- med to obtain a total score ranging from 5-50. The Patient Scar Assessment Scale consists of 6 items: scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item is ranked from 1- 10, with 1 representing normal skin. Total score ranges from 6-60.11

The primary outcomes were the POSAS score7,8 8 weeks after the CD. Secondary outcomes were surgeons’ satisfaction scale, duration of surgery, duration of hospitalization after the CD, and complications such as surgical site infection (SSI) or wound disruption (hematoma or seroma).

Statistical analysis We calculated the power analysis based on the assumption that a 20% (5-point) difference in POSAS score would influ- ence our clinical decision regarding the

APRIL 2017 Ameri

preferred method for skin closure, similar to previous studies that used this scoring system.11 The sample size calculation indicated 52 participants were needed for each arm of the study, using a ¼ 0.05 and 80% power.

Nominal data were described as numbers and percentages. Continuous data were assessed for normal distribu- tion (Shapiro-Wilk test) and were described as mean � SD or median (minimum-maximum). Quantitative data were analyzed using c2 test or Fisher exact test and continuous variables were compared between groups using t test or Mann-Whitney nonparametric test, as appropriate. P < .05 was considered statistically significant. Data were analyzed using statistical software (SPSS, V23, IBM Corp, Armonk, NY).

Results A total of 110 women agreed to partici- pate in the study. Three patients deliv- ered vaginally prior to randomization. One was scheduled for a CD for breech presentation that spontaneously turned to vertex. The other 2 were scheduled for an elective CD for breech presentation, but had external cephalic rotation per- formed after spinal anesthesia.

A total of 107 patients were random- ized and allocated to 2 intervention groups included in the data analysis. Three patients (2.8%) had an initial evaluation, but were lost to follow-up and did not arrive at the 8-week scar evaluation. The final analysis included 104 (97.2%) participants, 52 in the glue closure group and 52 in the suture group.

Demographic and obstetric charac- teristics are shown in Table 1. All the patients were Caucasian. There was no difference between the 2 groups regarding parity, maternal age, smoking, previous CD, or indications for CD. The prepregnancy body mass index (BMI) was not statistically different between the groups (P ¼ .457).

Surgeons’ scores, which are summa- rized in Table 2, include their estimation regarding closure time (P ¼ .181) and final closure appearance (P ¼ .082). These did not differ between groups. The mean satisfaction score was higher for

can Journal of Obstetrics & Gynecology 406.e2

TABLE 1 Demographic and clinical characteristics of study participants (n [ 104)

Variable Glue n ¼ 52 Suture n ¼ 52 P value Maternal age, y, mean � SD 35 � 4.3 34.44 � 4.9 .581 Gravidity, median (minimumemaximum) 3 (1e8) 3 (1e8) .125

Parity, median (minimumemaximum) 2 (0e6) 1 (0e6) .086

BMI, kg/m2, mean � SD (range) 28 � 5.8 (18.7e40.8) 29.1 � 7.3 (17.9e56.2) .457 Smokers, n (%) 3 (5.2) 3 (5.2) 1

Patients with previous CD, n (%) 37 (71.1) 34 (65.3) .527

No. of previous CD, median (minimumemaximum) 2 (1e4) 1 (1e3) .160

Surgical indications, n (%)

Breech presentation 14 (26.9) 17 (32.6) .520

Previous CD 37 (71.1) 34 (65.3) .527

Placenta previa 1 (1.9) 1 (1.9) 1

BMI, body mass index; CD, cesarean delivery.

Daykan et al. Skin closure at cesarean delivery: RCT of glue vs sutures. Am J Obstet Gynecol 2017.

TABLE 2 Surgeon’s satisfaction surveya

Survey question Glue group Suture group P value

Skin closure techniqueepersonal preference

3.8 � 1 (1e5) 4.4 � 0.6 (2e5) .003

Operating time estimated as longer 3.5 � 1.1 (1e5) 3.8 � 0.9 (2e5) .181 Closure appearance at end of CD 4.1 � 1 (1e5) 4.4 � 0.7 (3e5) .082 Values are expressed as mean � SD (range). CD, cesarean delivery.

a (1) How comfortable were you with technique? (not at all [1] to totally comfortable [5]); (2) Was estimated total operating time longer using glue/sutures compared to skin closure with staples? (not at all [1] to yes, a lot longer [5]); and (3) Were you satisfied with final closure appearance? (not at all [1] to yes, very satisfied [5]).

Daykan et al. Skin closure at cesarean delivery: RCT of glue vs sutures. Am J Obstet Gynecol 2017.

Original Research OBSTETRICS ajog.org

the suture group (P ¼ .003). The vari- ability between surgeons was not significant.

No significant differences were detected between the suture and glue groups in patients with hemoglobin decrease �2 g% (P ¼ .646), need for blood transfusion (P ¼ .314), opera- tive time (P ¼ .515), postoperative fever (P ¼ 1), and prolonged hospi- talization time >5 days (P ¼ 1) in either group (Table 3). In all, 103 pa- tients received prophylactic treatment with cephalosporin (1 patient in the glue group had a penicillin allergy and received clindamycin). The percentage of women with subcutaneous thick- ness >2 cm was similar in both groups (P ¼ .431).

The overall SSI rate was 3.8% (4/104). In the glue group, it was 5.7% (3/52) vs 1.9% (1/52) for the suture group (P ¼ .212). Overall wound disruption without signs of infection rate was 1.9% (2/104), and was not significantly different be- tween groups (2 [3.8%] vs 0 [0%], P ¼ .153). Prepregnancy BMI, subcutaneous fat thickness, and duration of surgery were similar between groups. There were no cases of deep organ infection.

No differences in subjective and objective scar ratings were detected be- tween the groups at 8 weeks after surgery

406.e3 American Journal of Obstetrics & Gynecol

(Table 4). Subcutaneous thickness >2 cm did not affect scar assessment either (Patient Scar Assessment Scale, P¼ .500; Observer Scar Assessment Scale, P ¼ .883). We calculated the data separately for primary and repeat CD and the results were similar.

Comment The major findings of our study are that closure of skin incision after CD with glue is as good as with sutures based on POSAS performed 8 weeks after surgery. Furthermore, parameters of SSI, length of postoperative hospitalization, and wound disruption were similar between the 2 study groups.

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We found that total operating time was similar between the sutures and glue groups. Previous studies showed longer operating time when closing the skin with sutures compared to staples.12,13

Interestingly, a recent Cochrane re- view14 that included 14 randomized clinical trials indicated significantly faster closure with sutures compared to tissue adhesives. In our cohort, closure time between glue and sutures were similar.

In our institution, surgeons are expe- rienced with sutures, staples, and glue closure methods. In this study, we eval- uated their satisfaction using glue or sutures, based on 3 questions asked

TABLE 3 Surgical characteristics

Variable Glue n ¼ 52 Suture n ¼ 52 P value Operative time, min, mean � SD 37.4 � 10.4 39 � 13.4 .515 Subcutaneous thickness >2 cm, n (%) 26 (50) 30 (58) .431

Patient with hemoglobin decrease �2 g%, n (%)

3 (5.7) 2 (3.8) .646

Blood transfusion, mean � SD 1 (1.9%) 0 .314 Postpartum fever >38�C, n (%) 1 (1.9) 1 (1.9) 1

Prolonged hospitalization �5 d, n (%) 1 (1.9) 1 (1.9) 1 Surgical site infection, n (%) 3 (5.7) 1 (1.9) .212

Wound disruption n (%) 2 (3.8) 0 .153

Daykan et al. Skin closure at cesarean delivery: RCT of glue vs sutures. Am J Obstet Gynecol 2017.

ajog.org OBSTETRICS Original Research

immediately after surgery. The survey results indicated that surgeons were more satisfied with the suture technique. Our results are in agreement with those of Mackeen et al,15 who found that obstetricians tended to have a strong preference for staples or sutures. Importantly, the glue has other advantages that should be taken into consideration, as it provides a water- proof barrier with antimicrobial properties.14,16

Wound complications remain an important source of morbidity after CD and can result in considerable costs to the patient and to the health care system. We did not find significant differences between the groups in blood loss, SSI, length of post-CD hospitalization, or wound disruption. Two study patients from the glue group (3.8%) experienced wound disruption and none of the patients from the suture group. These differences did not reach statistical significance, but require further

TABLE 4 Patient and Observer Scar Assessmen

Score Glue

PSAS 16.4 � 6.4 (4e36) OSAS 12.4 � 5.6 (6e27) Values are expressed as mean � SD (range). OSAS, Observer Scar Assessment Scale; PSAS, Patient Scar Ass

Daykan et al. Skin closure at cesarean delivery: RCT of glue

investigation. These results are in agree- ment with a retrospective study con- ducted by Siddiqui et al5 that investigated wound separation and SSI rates with glue compared to staples and subcuticular sutures. In contrast, ac- cording to a review14 designed to compare tissue adhesives with conven- tional skin closure techniques, sutures were better than tissue adhesives in rates of wound disruption. This review included only 1 small study on CD.14

Differences in the results might be related to different anatomical surgical sites and study designs. Our study was a randomized controlled trial with more participants. Therefore, our conclusions related to CD are likely to be more reliable. In our study, glue and suture skin

closure received similar POSAS scores 8 weeks after surgery by both patients and physicians. The POSASwas developed to evaluate all scar types (eg, linear scars, burn scars). It has been validated in

t Scale

Suture P value

16.9 � 6.2 (5e28) .710 11.7 � 5.2 (4e25) .568

essment Scale.

vs sutures. Am J Obstet Gynecol 2017.

APRIL 2017 Ameri

numerous studies, especially among dermatologists and plastic surgeons.7-9 A study conducted by Cromi et al11 was the first attempt to use this scale to evaluate abdominal wound healing in obstetrical care. Using POSAS, they found equiva- lent cosmetic appearance of CD scars when comparing staples and sub- cuticular sutures. A scar assessment scale, which subjectively evaluates the recovery of surgical wounds, is an important evaluation tool. To our knowledge, our study is the first to compare glue and subcuticular sutures in CD using POSAS.

The strengths of this study are that it compared the results of wound closure techniques using randomized controlled methods. In addition, it was powered to answer the research question. All CD were performed at a single academic institution with a uniform surgical technique, which strengthens the com- parisons between the study groups.

This study is not without limitations. Despite being powered to answer the primary outcome of the research ques- tion, it included a relatively small sample that was underpowered to answer the secondary outcomes of the study. Further investigation with larger sample sizes is indicated. We should also take into consideration that the POSAS is a subjective scoring system. However, biases of the patients and the observers could have potentially influenced both arms of the study. Therefore, despite its limitation, POSAS has been previously validated and is considered acceptable for scar assessment.7-9 Genetic and per- sonal tendencies of skin incision healing and scar tissue formation were not evaluated. It has been previously shown that these factors can affect scar tissue formation.17 Also, a larger study group would enable comparison of the effect of the number of previous surgeries as well as variations in subcutaneous thickness.

It would be interesting to investigate skin closure outcomes in patients with higher prepregnancy BMI and in pa- tients undergoing emergency CD in future studies. Also, the study was pow- ered for scar appearance but not to look at differences in SSI or wound disrup- tion, which are clinically important

can Journal of Obstetrics & Gynecology 406.e4

Original Research OBSTETRICS ajog.org

outcomes that need to be investigated further.

In summary, our study suggests that skin closure with glue following CD has similar results to subcuticular sutures. Both methods can be used interchange- ably based on surgeon and patient pref- erences. Future randomized controlled trials focusing on long-term cosmetic results of these techniques are still needed. n

References

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406.e5 American Journal of Obstetrics & Gynecol

incisions with octylcyanoacrylate: a multicenter randomized controlled trial. Surgery 2002;131:270-6. 7. Draaijers LJ, Tempelman FRH, Botman YA, et al. The Patient and Observer Scar Assess- ment Scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg 2004;113: 1960-7. 8. van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg 2005;116:514-22. 9. Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg 2007;119:487-94. 10. American College of Obstetricians and Gynecologists. Use of prophylactic antibi- otics in labor and delivery. ACOG Practice bulletin no. 120. Obstet Gynecol 2011;117: 1472-83. 11. Cromi A, Ghezzi F, Gottardi A, CherubinoM, Uccella S, Valdatta L. Cosmetic outcomes of various skin closuremethods following cesarean delivery: a randomized trial. Am J Obstet Gyne- col 2010;203:36.e1-8. 12. Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs sub- cuticular sutures. Am J Obstet Gynecol 2009;200:265.e1-4. 13. Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples

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compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol 2011;117:682-90. 14. Dumville JC, Coulthard P, Worthington HV, et al. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev 2014;11:CD004287. 15. Mackeen AD, Berghella V, Larsen M-L. Techniques and materials for skin closure in cesarean section. Cochrane Database Syst Rev 2012;11:CD003577. 16. Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to Dermabond. Am Fam Physician 2000;61: 1383-8. 17. Herzberger EH, Alon H, Hershko-Klement A, Ganor-Paz Y, Fejgin MD, Biron-Shental T. Adhesions at repeat cesarean delivery: is there a personal impact? Arch Gynecol Obstet 2015;292:813-8.

Author and article information From the Department of Obstetrics and Gynecology (all

authors) and Genetics Institute (Dr Sukenik-Halevy), Meir

Medical Center, Kfar Saba, and Sackler School of Medi-

cine, Tel Aviv University, Tel Aviv (all authors), Israel. 1These authors contributed equally to this article.

Received Nov. 14, 2016; revised Dec. 20, 2016;

accepted Jan. 13, 2017.

The authors report no conflict of interest.

Presented as an oral abstract at the 37th Annual

Pregnancy Meeting of the Society for Maternal-Fetal

Medicine, Las Vegas, NV, Jan. 23-28, 2017.

Corresponding author: Yair Daykan, MD. yair.dykan@

gmail.com