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NCT01724255 Clinical Trial

Optimal Time for Staple/Dressing Removal

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01724255
Other study ID # StapleDressingRemoval-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received November 7, 2012
Last updated July 26, 2015
Start date January 2013
Est. completion date December 2014

Study information
Verified date July 2015
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date December 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- patients undergoing a cesarean section at our facility

Exclusion Criteria:

- patients lost to follow up

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Wound infection and complications 6 weeks No
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