Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.

Study Overview
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Brief Summary
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The optimal choice of skin closure at cesarean delivery has not yet been determined. This study will compare 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.

Detailed Description
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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 cesarean delivery. 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 Staphylococcus 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 clinical 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. 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. Previous studies regarding skin closure with glue were small, retrospective, and included mixed populations and varying surgical techniques. Therefore, clear, conclusive recommendations are lacking. 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 will not be dressed with an abdominal pad or adhesive tape according to manufacturer's instructions.

Official Title
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Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures: A Randomized Clinical Trial

Conditions
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Cesarean Wound; Dehiscence

Intervention / Treatment
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* Procedure: Glue (Dermabond®; Ethicon, Somerville, NJ).
* Procedure: Monocryl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal Age: 20-40 years old. BMI: 18.5 - 29.9 kg/m2. Gestational Age: term pregnancy (≥ 37 weeks) and viable fetus. Scheduled to undergo elective lower segment CD (category 4 CD). Hemoglobin level: ≥ 10 gm/dl. Exclusion Criteria: Abnormal placental invasion (e.g., placenta previa). Emergency CD (category 1, 2 and 3 CD). Clinical signs of infection at the time of CD. Medical disorder (Diabetes, Hypertension, Cardiac, Hepatic or renal disorder). Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids). Previous CD not using Pfannenstiel method (e.g., midline incision). Known hypersensitivity to any of the suture materials or glue used in the protocol, or any disorders requiring chronic corticosteroids or immune suppressants. History of surgical site infection after previous CD.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glue<br>Skin closure after cesarean section using glue | Procedure: Glue (Dermabond®; Ethicon, Somerville, NJ).<br>* Arm 1: Skin after cesarean section will be closed by glue<br>|
| Active Comparator: Monocryl<br>Skin closure after cesarean section using running subcuticular sutures using synthetic monofilament | Procedure: Monocryl<br>* Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient and Observer Scar Assessment Scale (POSASv2.0): | In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The directions for use of the different parameters of the Observer Scale POSASv2.0 are as follows (all parameters should be compared to normal skin at a comparable anatomical site whenever possible):The Patient Scale contains six questions applying to pain, itching, colour, pliability, thickness and relief.Each of the six items on both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1' and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable | one week after cesarean section | 
| The Patient and Observer Scar Assessment Scale (POSASv2.0): | In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The directions for use of the different parameters of the Observer scale POSASv2.0 are as follows ( all parameters should be compared to normal skin at a comparable anatomical site whenever possible): The Patient scale contains six questions applying to pain, itching, colour, pliability, thickness and relief. Each of the six items on both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is 1 and correspons to the situation of normal skin( normal pigmentation, no itching etc.) and goes up to the worst imaginable | one month after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeons' satisfaction scale: | Surgeons' satisfaction scale with each closure method (glue vs sutures) is 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 compared to skin closure with sutures? (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]) | immediately after the procedure | 
| Duration of surgery | the duration of skin closure using glue or Monocryl will be measures in minutes | in minutes from closure of the subcutaneous fat layer to closure of the skin |