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

Not Applicable

• Conditions: Postpartum Bleeding; Vaginal Lacerations; Cervical Lacerations
• Interventions: Device: The HemCon GuardaCare; Device: Control

• Registration Number: NCT01373801
• Lead Sponsor: Soroka University Medical Center

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 available

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Study Start: 2011-07
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-10
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	The HemCon GuardaCare	-
Control	Control	-
GuardaCare	The HemCon GuardaCare	-

Primary Outcome Measures

Name	Time	Method
Cessation of bleeding after a 30 minutes	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

Name	Time	Method
Procedural success	6 hours	Procedural success defined as a cessation of bleeding at 6 hours.
Safety composite endpoint	7 days	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	6 hours	Device success defined as a cessation of bleeding at 6 hours using only the allocated device.

Trial Locations

Locations (1)

OB\GYN Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel