MedTrace Logo

Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section

NCT03052647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-02-15

No results posted yet for this study

Summary

The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.

Conditions

  • Wound

Interventions

DEVICE

Dermaclip

Dermaclip is an adhesive latch device used for skin closure

DEVICE

Subcuticular suture

subcuticular suture will be used as the device to close the skin in this arm

Sponsors & Collaborators

  • Rubino Ob-Gyn Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-11-30
Completion
2018-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03052647 on ClinicalTrials.gov