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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2011

Last Updated Date

August 9, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01373801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Postpartum Bleeding
Vaginal Lacerations
Cervical Lacerations

Intervention ^ICMJE

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.

Study Arm (s)

Active Comparator: Control
Interventions:
- Device: The HemCon GuardaCare
- Device: Control
Experimental: GuardaCare
Intervention: Device: The HemCon GuardaCare

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed Informed Consent
Age≥18 year
Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration

Exclusion Criteria:

Subjects undertaking anticoagulation treatment
Pre-existing coagulopathy
Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
Systolic blood pressure <90mmHg
Shellfish allergy

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01373801

Other Study ID Numbers ^ICMJE

sor517911ctil

Has Data Monitoring Committee

Responsible Party

Prof. Arnon Wiznitzer, Head of Obstetrics and Gynecology Division, Soroka University Medical Center

Study Sponsor ^ICMJE

Soroka University Medical Center

Collaborators ^ICMJE

HemCon Medical Technologies, Inc

Investigators ^ICMJE

Principal Investigator:	Arnon Wiznitzer, M.D	Soroka University Medical Center
Principal Investigator:	Victor Novack, M.D. PhD	Soroka University Medical Center

Information Provided By

Soroka University Medical Center

Verification Date

April 2011

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

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