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Early Bandage Removal Post-Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867567
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
David Peleg, Ziv Hospital

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.

Condition or disease Intervention/treatment Phase
Wound Disruption Wound Infection Procedure: abdominal bandage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Early Bandage Removal Post-Cesarean Delivery
Study Start Date : August 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 6 Hours
Removal of bandage after 6 hours
Procedure: abdominal bandage
Active Comparator: 24 hours
removal of bandage after 24 hours
Procedure: abdominal bandage



Primary Outcome Measures :
  1. Wound Disruption [ Time Frame: 5 - 7 days ]

Secondary Outcome Measures :
  1. Wound Infection [ Time Frame: 5 - 7 days ]
  2. Patient satisfaction [ Time Frame: 5 - 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867567


Locations
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Israel
Ziv Medical center
Tsefat, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
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Responsible Party: David Peleg, Staff Physician, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01867567    
Other Study ID Numbers: CSBandage
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
Keywords provided by David Peleg, Ziv Hospital:
cesarean
bandage removal
infection
disruption
satisfaction
patient satisfaction
Additional relevant MeSH terms:
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Wound Infection
Wounds and Injuries
Infection