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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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.
Standard packing gauze roll bandage.
OB\GYN Soroka University Medical Center
Beersheba, Israel
RECRUITINGCessation of bleeding after a 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.
Time frame: 30 minutes
Safety composite endpoint
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
Time frame: 7 days
Device Success
Device success defined as a cessation of bleeding at 6 hours using only the allocated device.
Time frame: 6 hours
Procedural success
Procedural success defined as a cessation of bleeding at 6 hours.
Time frame: 6 hours
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