MedTrace Logo

Postoperative Pain and Skin Closure Methods After Cesarean Section

NCT02028000 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-10-24

No results posted yet for this study

Summary

The study is looking at women undergoing cesarean section delivery of their baby. The purpose of this research study is to determine what type of skin closure after cesarean section helps decrease pain level the most and improves the appearance of the incision site.

The study hypothesis is to determine if skin closure with absorbable subcuticular staples leads to improved cosmesis and/or decreased post-operative pain.

Participants in the study will already be scheduled for a cesarean section for delivery of their baby. They will be randomized into one of three groups, 1) Insorb (absorbable subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their cesarean section. Information that will be recorded includes amount of pain medication usage while in the hospital after cesarean section, daily patient rated pain score until discharge from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks after surgery.

Conditions

  • Pregnancy

Interventions

PROCEDURE

Insorb staples skin closure

Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.

PROCEDURE

Monocryl skin closure

Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.

PROCEDURE

Vicryl skin closure

Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Joshua Nitsche, MD, PhD · Wake Forest Baptist School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-01-01
Completion
2016-01-01

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 NCT02028000 on ClinicalTrials.gov