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

NCT04302597 | Completed DMC

• 1 other identifier: GLUE-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

Cesarean delivery; Cosmesis; Healing; Skin closure; Scar assessment scales

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Scar Assessment Scale (PSAS) score

  6 months after repeated cesarean section

Study Arms (2)

Staples

ACTIVE COMPARATOR

Women who underwent repeated cesarean section with skin closure using staples.

Procedure: Staples

Tissue adhesive

EXPERIMENTAL

Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive.

Procedure: Tissue adhesive

Interventions

Staples PROCEDURE

Skin closure using surgical stapler.

Staples

Tissue adhesive PROCEDURE

Skin closure using 2-octylcyanoacrylate tissue adhesive.

Tissue adhesive

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Ospedale "Filippo Del Ponte"

Varese, Lombardy, 21100, Italy

Location

MeSH Terms

Interventions

Sutures; Tissue Adhesives

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Antonella Cromi, M.D., Ph.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Fabio Ghezzi, M.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

• Antonio Simone Laganà, M.D., Ph.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center, prospective, randomized controlled trial

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: May 15, 2020
• Primary Completion: January 30, 2021
• Study Completion: July 15, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)