Clinical Trial: Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS
Brief Summary: The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.
Detailed Summary:
Sponsor: Soroka University Medical Center
Current Primary Outcome: Cessation of bleeding after a 30 minutes [ Time Frame: 30 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety composite endpoint [ Time Frame: 7 days ]
Rate of the safety composite (any of the following):
- Anaphylaxis or allergic reaction
- Recurrent Hospitalization
- Serious adverse events
- Need for the repeated surgical intervention
- Need for blood products transfusion
- Local Infection In addition individual rates of the components will be reported
- Device Success [ Time Frame: 6 hours ]Device success defined as a cessation of bleeding at 6 hours using only the allocated device.
- Procedural success [ Time Frame: 6 hours ]Procedural success defined as a cessation of bleeding at 6 hours.
Original Secondary Outcome: Same as current
Information By: Soroka University Medical Center
Dates:
Date Received: June 13, 2011
Date Started: July 2011
Date Completion:
Last Updated: August 9, 2011
Last Verified: April 2011