Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
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|ClinicalTrials.gov Identifier: NCT01373801|
Recruitment Status : Unknown
Verified April 2011 by Soroka University Medical Center.
Recruitment status was: Recruiting
First Posted : June 15, 2011
Last Update Posted : August 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Bleeding Vaginal Lacerations Cervical Lacerations||Device: The HemCon GuardaCare Device: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2012|
|Active Comparator: Control||
Device: The HemCon GuardaCare
The HemCon GuardaCare (HemCon Medical Technologies Inc., Portland, OR) is a hemostatic dressing made of chitosan, a complex carbohydrate derived from chitin from shellfish and is designed as a hemostatic dressing, and a topical antimicrobial dressing. GuardaCare contains no pro-clotting agents, providing a safe and localized hemostatic solution and is latex free and sterile.Device: Control
Standard packing gauze roll bandage.
Device: The HemCon GuardaCare
The HemCon GuardaCare (HemCon Medical Technologies Inc., Portland, OR) is a hemostatic dressing made of chitosan, a complex carbohydrate derived from chitin from shellfish and is designed as a hemostatic dressing, and a topical antimicrobial dressing. GuardaCare contains no pro-clotting agents, providing a safe and localized hemostatic solution and is latex free and sterile.
- 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.
- 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.
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): NCT01373801
|Contact: Arnon Wiznitzer, MDfirstname.lastname@example.org|
|Contact: Ayala Dvir, MsCemail@example.com|
|OB\GYN Soroka University Medical Center||Recruiting|
|Beer Sheva, Israel, 84101|
|Contact: Ayala Dvir, MsC 972-8-62444245 firstname.lastname@example.org|
|Principal Investigator: Arnon Wiznitzer, MD|
|Principal Investigator:||Arnon Wiznitzer, M.D||Soroka University Medical Center|
|Principal Investigator:||Victor Novack, M.D. PhD||Soroka University Medical Center|