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

Primary Purpose

Postpartum Bleeding, Vaginal Lacerations, Cervical Lacerations

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The HemCon GuardaCare
Control
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Bleeding focused on measuring Postpartum women, after surgical repair of vaginal and cervical lacerations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • OB\GYN Soroka University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

GuardaCare

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Device Success
Device success defined as a cessation of bleeding at 6 hours using only the allocated device.
Procedural success
Procedural success defined as a cessation of bleeding at 6 hours.

Full Information

First Posted
June 13, 2011
Last Updated
August 9, 2011
Sponsor
Soroka University Medical Center
Collaborators
HemCon Medical Technologies, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01373801
Brief Title
Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
Official Title
THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center
Collaborators
HemCon Medical Technologies, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Bleeding, Vaginal Lacerations, Cervical Lacerations
Keywords
Postpartum women, after surgical repair of vaginal and cervical lacerations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
GuardaCare
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
The HemCon GuardaCare
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Standard packing gauze roll bandage.
Primary Outcome Measure Information:
Title
Cessation of bleeding after a 30 minutes
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Safety composite endpoint
Description
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
Time Frame
7 days
Title
Device Success
Description
Device success defined as a cessation of bleeding at 6 hours using only the allocated device.
Time Frame
6 hours
Title
Procedural success
Description
Procedural success defined as a cessation of bleeding at 6 hours.
Time Frame
6 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Wiznitzer, MD
Phone
972-8-6400774
Email
arnonw@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ayala Dvir, MsC
Phone
972-8-6244245
Email
ayaladv@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Wiznitzer, M.D
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Novack, M.D. PhD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
OB\GYN Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayala Dvir, MsC
Phone
972-8-62444245
Email
ayaladv@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Arnon Wiznitzer, MD

12. IPD Sharing Statement

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

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