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NCT01867567 Clinical Trial

Early Bandage Removal Post-Cesarean Delivery

Wound Infection Clinical Trial

Official title:
Early Bandage Removal Post-Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01867567
Other study ID # CSBandage
Secondary ID
Status Completed
Phase N/A
First received May 26, 2013
Last updated December 29, 2015
Start date August 2013
Est. completion date April 2015

Study information
Verified date December 2015
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

Intervention

Procedure:
• abdominal bandage

Locations
Country Name City State
Israel Ziv Medical center Tsefat

Sponsors (1)
Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Disruption 5 - 7 days Yes
Secondary Wound Infection 5 - 7 days Yes
Secondary Patient satisfaction 5 - 7 days No
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