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| Name | Class |
|---|---|
| HemCon Medical Technologies, Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| GuardaCare | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The HemCon GuardaCare | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety composite endpoint | Rate of the safety composite (any of the following):
| 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnon Wiznitzer, MD | Contact | 972-8-6400774 | arnonw@clalit.org.il | |
| Ayala Dvir, MsC | Contact | 972-8-6244245 | ayaladv@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Arnon Wiznitzer, M.D | Soroka University Medical Center | Principal Investigator |
| Victor Novack, M.D. PhD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OB\GYN Soroka University Medical Center | Recruiting | Beersheba | 84101 | Israel |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Control | Device | Standard packing gauze roll bandage. |
|
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |