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

Soroka University Medical Center

Status: Unknown

Conditions: Postpartum Bleeding; Vaginal Lacerations; Cervical Lacerations

Treatments: Device: Control; Device: The HemCon GuardaCare

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01373801

sor517911ctil

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Device: Control

Device: The HemCon GuardaCare

GuardaCare

Experimental group

Treatment:

Device: The HemCon GuardaCare