Cervical Lacerations, Postpartum Bleeding, Vaginal Lacerations
Conditions
Keywords
Postpartum women, after surgical repair of vaginal and cervical lacerations
Brief 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.
Interventions
DEVICEThe 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.
DEVICEControl
Standard packing gauze roll bandage.
Sponsors
HemCon Medical Technologies, Inc
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent 2. Age≥18 year 3. Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration
Exclusion criteria
1. Subjects undertaking anticoagulation treatment 2. Pre-existing coagulopathy 3. Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery. 4. Systolic blood pressure \<90mmHg 5. Shellfish allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of bleeding after a 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety composite endpoint | 7 days | 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 |
| Device Success | 6 hours | Device success defined as a cessation of bleeding at 6 hours using only the allocated device. |
| Procedural success | 6 hours | Procedural success defined as a cessation of bleeding at 6 hours. |
Countries
Israel
Contacts
Primary ContactArnon Wiznitzer, MD
Backup ContactAyala Dvir, MsC
Outcome results
None listed