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 ]

The primary endpoint is a cessation of bleeding after a 30 minute period. Evaluation of bleeding will be performed by an independent evaluator, who will determine if the bleeding has stopped.


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):

    1. Anaphylaxis or allergic reaction
    2. Recurrent Hospitalization
    3. Serious adverse events
    4. Need for the repeated surgical intervention
    5. Need for blood products transfusion
    6. 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