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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Bleeding, Vaginal Lacerations, Cervical Lacerations

Intervention / Treatment
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* Device: The HemCon GuardaCare
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Age≥18 year Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration Exclusion Criteria: Subjects undertaking anticoagulation treatment Pre-existing coagulopathy Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery. Systolic blood pressure <90mmHg Shellfish allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Device: The HemCon GuardaCare<br>* 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.<br>Device: Control<br>* Standard packing gauze roll bandage.<br>|
| Experimental: GuardaCare<br> | Device: The HemCon GuardaCare<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation 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. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety composite endpoint | 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 | 7 days | 
| Device Success | Device success defined as a cessation of bleeding at 6 hours using only the allocated device. | 6 hours | 
| Procedural success | Procedural success defined as a cessation of bleeding at 6 hours. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum women, after surgical repair of vaginal and cervical lacerations