Early Bandage Removal Post-Cesarean Delivery

December 29, 2015 updated by: David Peleg, Ziv Hospital
Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tsefat, Israel, 13100
        • Ziv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age of 18 to 44
  • elective cesarean section, primary or repeat
  • low risk pregnancy

Exclusion Criteria:

  • under the age of 18 and above the age of 44
  • diabetes, preeclampsia or other pregnancy complications
  • unable or unwilling to give informed consent
  • chorioamnionitis
  • BMI over 35
  • more than 3 cesareans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6 Hours
Removal of bandage after 6 hours
Procedure: abdominal bandage
Active Comparator: 24 hours
removal of bandage after 24 hours
Procedure: abdominal bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound Disruption
Time Frame: 5 - 7 days
5 - 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Wound Infection
Time Frame: 5 - 7 days
5 - 7 days
Patient satisfaction
Time Frame: 5 - 7 days
5 - 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 26, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSBandage

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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