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A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure

NCT01753518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2015-04-30

Study results available
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Summary

Currently, the way doctors close the skin during cesarean section is different between surgeons and there is little evidence to support the use of one kind of closure over the other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable suture (or stitch), placed within the top layer of skin. At other institutions, a metal staple is often used to close the skin.

There is a new technique that uses special absorbable staples just beneath the skin. This technology may be equal to, or possibly better than, current skin closure techniques. However, there is currently little data to show how it compares. The purpose of this study is to compare the absorbable staple to the currently used absorbable suture. The data from this study will then be used to help determine the best technique for skin closure.

Conditions

  • Surgical Wound

Interventions

DEVICE

Subcuticular suture

subcuticular Monocryl suture closure

DEVICE

Subcuticular staple

subcuticular staple wound closure with INSORB 20 device

Sponsors & Collaborators

  • Margaret L. Dow, M.D.

    lead OTHER

Principal Investigators

  • Jennifer Tessmer-Tuck, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-04-30
Completion
2014-06-30

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 NCT01753518 on ClinicalTrials.gov