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

Postpartum Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01373801
• Other study ID #: sor517911ctil
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2011
• Last updated: August 9, 2011
• Start date: July 2011

Study information

• Verified date: April 2011
• Source: Soroka University Medical Center
• Contact: Arnon Wiznitzer, MD
• Phone: 972-8-6400774
• Email: arnonw[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Lacerations
• Hemorrhage
• Lacerations
• Postpartum Bleeding
• Postpartum Hemorrhage
• Vaginal Lacerations

Intervention

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.
• Control
Standard packing gauze roll bandage.

Locations

Country	Name	City	State
Israel	OB\GYN Soroka University Medical Center	Beer Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	HemCon Medical Technologies, Inc

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Device Success	Device success defined as a cessation of bleeding at 6 hours using only the allocated device.	6 hours	No
Secondary	Procedural success	Procedural success defined as a cessation of bleeding at 6 hours.	6 hours	No