NCT01373801

Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations

THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postpartum Bleeding
• Vaginal Lacerations
• Cervical Lacerations

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• First posted: 2011-06-15
• Last updated: 2011-08-10

Locations

1 site across 1 country: Israel