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Early Bandage Removal Post-Cesarean Delivery

NCT ID: NCT01867567

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Disruption Wound Infection

Keywords

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cesarean bandage removal infection disruption satisfaction patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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6 Hours

Removal of bandage after 6 hours

Group Type EXPERIMENTAL

abdominal bandage

Intervention Type PROCEDURE

24 hours

removal of bandage after 24 hours

Group Type ACTIVE_COMPARATOR

abdominal bandage

Intervention Type PROCEDURE

Interventions

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abdominal bandage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Peleg

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ziv Medical center

Safed, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CSBandage

Identifier Type: -

Identifier Source: org_study_id