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. 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.

There is currently no definite evidence regarding the best method for skin closure after CD. Staples have been suggested as inferior to other techniques. Given the conflicting data available, obstetricians are forced to base their decisions on personal preference. Dermabond glue (Ethicon Inc, Somerville, 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 (methicillin-resistant Staphylococcus aureus and S epidermidis ) and gram-negative ( Escherichia coli ) bacteria. 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. Also, glue was shown to be well-accepted by patients.

To date, there have been no randomized controlled trials comparing skin closure with glue to sutures using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS is a validated and reliable instrument that is practical for assessing scars. 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 preoperative 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 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 mellitus (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 protocol, 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 administered to all patients within 60 minutes before skin incision, based on American Congress of Obstetricians and Gynecologists recommendations.

Scars from previous CD were 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 recommendations, 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 according to manufacturer’s instructions. In the suture group, the skin was closed with Monocryl (poliglecaprone) 3-0 placed under the skin using a blind suture technique. Steri-Strips (3M Corp, 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 surgery: (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 appearance? (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.

The Observer Scar Assessment Scale rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable is ranked from 1-10, with 1 representing normal skin. Ratings are summed 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.

The primary outcomes were the POSAS score 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).

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 preoperative 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 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 mellitus (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 protocol, 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 administered to all patients within 60 minutes before skin incision, based on American Congress of Obstetricians and Gynecologists recommendations.

Scars from previous CD were 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 recommendations, 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 according to manufacturer’s instructions. In the suture group, the skin was closed with Monocryl (poliglecaprone) 3-0 placed under the skin using a blind suture technique. Steri-Strips (3M Corp, 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 surgery: (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 appearance? (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.

The Observer Scar Assessment Scale rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable is ranked from 1-10, with 1 representing normal skin. Ratings are summed 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.

The primary outcomes were the POSAS score 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).