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

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Procedure: Staples; Procedure: Tissue adhesive

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Varese, Lombardia, Italy, 21100
      • Ospedale "Filippo Del Ponte"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Study Chair: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria; Principal Investigator: Antonella Cromi, M.D., Ph.D., Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 7, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cesarean delivery; Healing; Cosmesis; Skin closure; Scar assessment scales
• Other Study ID Numbers: GLUE-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No