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

NCT01373801 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2011-08-10

No results posted yet for this study

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.

Conditions

  • Postpartum Bleeding
  • Vaginal Lacerations
  • Cervical Lacerations

Interventions

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.

Sponsors & Collaborators

  • HemCon Medical Technologies, Inc

    collaborator INDUSTRY

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Arnon Wiznitzer, M.D · Soroka University Medical Center

  • Victor Novack, M.D. PhD · Soroka University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01373801 on ClinicalTrials.gov