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

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

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 Overview

• Status: Unknown
• Conditions: Postpartum Bleeding; Vaginal Lacerations; Cervical Lacerations
• Intervention / Treatment: Device: The HemCon GuardaCare; Device: Control

• Study Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnon Wiznitzer, MD; Phone Number: 972-8-6400774; Email: arnonw@clalit.org.il
• Study Contact Backup: Name: Ayala Dvir, MsC; Phone Number: 972-8-6244245; Email: ayaladv@clalit.org.il

Study Locations

• Israel
  • Beer Sheva, Israel, 84101
    • Recruiting
    • OB\GYN Soroka University Medical Center
    • Contact: Ayala Dvir, MsC; Phone Number: 972-8-62444245; Email: ayaladv@clalit.org.il
    • Principal Investigator: Arnon Wiznitzer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	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.; Device: Control; Standard packing gauze roll bandage.
Experimental: GuardaCare	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: HemCon Medical Technologies, Inc
• Investigators: Principal Investigator: Arnon Wiznitzer, M.D, Soroka University Medical Center; Principal Investigator: Victor Novack, M.D. PhD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 9, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Postpartum women, after surgical repair of vaginal and cervical lacerations
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Lacerations
• Other Study ID Numbers: sor517911ctil