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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
HemCon Medical Technologies, Inc
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01373801
First received: June 13, 2011
Last updated: August 9, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Postpartum Bleeding
Vaginal Lacerations
Cervical Lacerations
Device: The HemCon GuardaCare
Device: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Cessation of bleeding after a 30 minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Safety composite endpoint [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Device success defined as a cessation of bleeding at 6 hours using only the allocated device.

  • Procedural success [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Procedural success defined as a cessation of bleeding at 6 hours.


Estimated Enrollment: 85
Study Start Date: July 2011
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373801

Contacts
Contact: Arnon Wiznitzer, MD 972-8-6400774 arnonw@clalit.org.il
Contact: Ayala Dvir, MsC 972-8-6244245 ayaladv@clalit.org.il

Locations
Israel
OB\GYN Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact: Ayala Dvir, MsC    972-8-62444245    ayaladv@clalit.org.il   
Principal Investigator: Arnon Wiznitzer, MD         
Sponsors and Collaborators
Soroka University Medical Center
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
  More Information

No publications provided

Responsible Party: Prof. Arnon Wiznitzer, Head of Obstetrics and Gynecology Division, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01373801     History of Changes
Other Study ID Numbers: sor517911ctil
Study First Received: June 13, 2011
Last Updated: August 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Postpartum women, after surgical repair of vaginal and cervical lacerations

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Lacerations
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Wounds and Injuries

ClinicalTrials.gov processed this record on August 27, 2014