Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section

Study Overview
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Brief Summary
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Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods. Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.

Official Title
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Cosmetic Outcomes After Skin Closure of Pfannenstiel Incision With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section

Conditions
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Cesarean Section

Intervention / Treatment
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* Procedure: Staples
* Procedure: Tissue adhesive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section) Maternal age 18-45 years Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus Exclusion Criteria: History of keloids Previous transversal suprapubic scars Clinical signs of infection and/or tattoos in the area to be studied Known patient hypersensitivity to any of the suture materials used in the protocol BMI below 20 or above 30 Any medical disorder that could affect wound healing, including severe malnutrition, conditions requiring chronic corticosteroid use or immune suppressant, uncontrolled diabetes mellitus (defined as Hemoglobin A1c > 6%, unbalanced daily glucose measurements, and fasting glucose >95 mg/dL).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Interventional Model Description: Single-center, prospective, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staples<br>Women who underwent repeated cesarean section with skin closure using staples. | Procedure: Staples<br>* Skin closure using surgical stapler.<br>|
| Experimental: Tissue adhesive<br>Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive. | Procedure: Tissue adhesive<br>* Skin closure using 2-octylcyanoacrylate tissue adhesive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer Scar Assessment Scale (OSAS) score | The Observer Scar Assessment Scale (OSAS) rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable uses a 10-point scoring system, with 1 representing normal skin. Ratings of individual variables may be summed to obtain a total score ranging from 5-50, with 5 representing normal skin. | 6 months after repeated cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Scar Assessment Scale (PSAS) score | The Patient Scar Assessment Scale (PSAS) consists of 6 items on scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item uses a 10-point scoring system, summed to obtain a total score ranging from 6-60, with 6 representing normal skin with no associated symptoms. | 6 months after repeated cesarean section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmesis, Cesarean delivery, Healing, Skin closure, Scar assessment scales