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

NCT01373801 | Unknown

• 1 other identifier: sor517911ctil
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Bleeding; Vaginal Lacerations; Cervical Lacerations

Keywords

Postpartum women, after surgical repair of vaginal and cervical lacerations

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes

Secondary Outcomes (3)

• Safety composite endpoint

  7 days

• Device Success

  6 hours

• Procedural success

  6 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Device: The HemCon GuardaCare; Device: Control

GuardaCare

EXPERIMENTAL

Device: The HemCon GuardaCare

Interventions

The HemCon GuardaCare 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; GuardaCare

Control DEVICE

Standard packing gauze roll bandage.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Soroka University Medical Center: lead
• HemCon Medical Technologies, Inc: collaborator

Study Sites (1)

OB\GYN Soroka University Medical Center

Beersheba, 84101, Israel

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnon Wiznitzer, M.D

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

• Victor Novack, M.D. PhD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnon Wiznitzer, MD

CONTACT

972-8-6400774; arnonw@clalit.org.il

Ayala Dvir, MsC

CONTACT

972-8-6244245; ayaladv@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Last Updated: August 10, 2011

Record last verified: 2011-04

Locations

IL (1)