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

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: Staples; Procedure: Tissue adhesive

• Registration Number: NCT04302597
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-07
• Study First Posted: 2020-03-10
• Study Start: 2020-05-15
• Primary Completion: 2021-01-30
• Study Completion: 2021-07-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Staples	Staples	Women who underwent repeated cesarean section with skin closure using staples.
Tissue adhesive	Tissue adhesive	Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive.

Primary Outcome Measures

Name	Time	Method
Observer Scar Assessment Scale (OSAS) score	6 months after repeated cesarean section	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.

Secondary Outcome Measures

Name	Time	Method
Patient Scar Assessment Scale (PSAS) score	6 months after repeated cesarean section	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.

Trial Locations

Locations (1)

Ospedale "Filippo Del Ponte"; 🇮🇹 Varese, Lombardia, Italy