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

NCT ID: NCT01373801

Last Updated: 2011-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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

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Conditions

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Postpartum Bleeding Vaginal Lacerations Cervical Lacerations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

The HemCon GuardaCare

Intervention Type DEVICE

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.

Control

Intervention Type DEVICE

Standard packing gauze roll bandage.

GuardaCare

Group Type EXPERIMENTAL

The HemCon GuardaCare

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Control

Standard packing gauze roll bandage.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HemCon Medical Technologies, Inc

INDUSTRY

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Soroka University Medical Center

Principal Investigators

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Arnon Wiznitzer, M.D

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Victor Novack, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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OB\GYN Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Arnon Wiznitzer, MD

Role: CONTACT

972-8-6400774

Ayala Dvir, MsC

Role: CONTACT

972-8-6244245

Facility Contacts

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Ayala Dvir, MsC

Role: primary

972-8-62444245

Other Identifiers

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sor517911ctil

Identifier Type: -

Identifier Source: org_study_id

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