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

June 13, 2011
August 9, 2011
July 2011
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01373801 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postpartum Bleeding
  • Vaginal Lacerations
  • Cervical Lacerations
  • 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.
  • Active Comparator: Control
    Interventions:
    • Device: The HemCon GuardaCare
    • Device: Control
  • Experimental: GuardaCare
    Intervention: Device: The HemCon GuardaCare
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
Not Provided
July 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Arnon Wiznitzer, MD 972-8-6400774 arnonw@clalit.org.il
Contact: Ayala Dvir, MsC 972-8-6244245 ayaladv@clalit.org.il
Israel
 
NCT01373801
sor517911ctil
No
Prof. Arnon Wiznitzer, Head of Obstetrics and Gynecology Division, Soroka University Medical Center
Soroka University Medical Center
HemCon Medical Technologies, Inc
Principal Investigator: Arnon Wiznitzer, M.D Soroka University Medical Center
Principal Investigator: Victor Novack, M.D. PhD Soroka University Medical Center
Soroka University Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP