Optimal Time for Staple/Dressing Removal

July 26, 2015 updated by: Hadassah Medical Organization

The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing

The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients:

  1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1
  2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4
  3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1
  4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7
  5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7

Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1500

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
      • Jerusalem, Israel
        • Hadassah Medical Organization

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing a cesarean section at our facility

Description

Inclusion Criteria:

  • patients undergoing a cesarean section at our facility

Exclusion Criteria:

  • patients lost to follow up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
staple removal day 4 dressing removal day 1
early staple removal and early dressing removal
Other: questionnaire
staple removal day 4 dressing removal day 4
early staple removal and day 4 dressing removal
Other: questionnaire
staple removal day 7, dressing removal day 1
late staple removal and early dressing removal
Other: questionnaire
staple removal day 7, dressing removal day 7
late staple removal and late dressing removal
Other: questionnaire
staple removal day 7, dressing removal day 4
late staple removal and day 4 dressing removal
Other: questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Wound infection and complications
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 9, 2012

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 26, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StapleDressingRemoval-HMO-CTIL

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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