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Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

NCT05112640 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-08-21

Study results available
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Summary

Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.

Conditions

  • Operative Time
  • Wound Heal

Interventions

DEVICE

INSORB: subcuticular stapling device

Under the skin stapling device that delivers absorbable staples

DEVICE

Subcuticular monocryl suture manufactured by Ethicon

Under the skin suture placed by hand

Sponsors & Collaborators

  • Cooper Companies

    collaborator INDUSTRY

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2023-12-31
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05112640 on ClinicalTrials.gov