NCT01867567

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

May 26, 2013

Last Update Submit

December 29, 2015

Conditions

Wound DisruptionWound Infection

Keywords

cesareanbandage removalinfectiondisruptionsatisfactionpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Wound Disruption

    5 - 7 days

Secondary Outcomes (2)

  • Wound Infection

    5 - 7 days

  • Patient satisfaction

    5 - 7 days

Study Arms (2)

6 Hours

EXPERIMENTAL

Removal of bandage after 6 hours

Procedure: abdominal bandage

24 hours

ACTIVE COMPARATOR

removal of bandage after 24 hours

Procedure: abdominal bandage

Interventions

abdominal bandagePROCEDURE
24 hours6 Hours

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Wound InfectionInfectionsPersonal SatisfactionPatient Satisfaction

Condition Hierarchy (Ancestors)

BehaviorTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

May 26, 2013

First Posted

June 4, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

IL(1)