Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
NCT ID: NCT01373801
Last Updated: 2011-08-10
Study Results
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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UNKNOWN
NA
85 participants
INTERVENTIONAL
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
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.
Control
Standard packing gauze roll bandage.
GuardaCare
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.
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.
Control
Standard packing gauze roll bandage.
Eligibility Criteria
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Inclusion Criteria
2. Age≥18 year
3. Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration
Exclusion Criteria
2. Pre-existing coagulopathy
3. Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
4. Systolic blood pressure \<90mmHg
5. Shellfish allergy
18 Years
FEMALE
No
Sponsors
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HemCon Medical Technologies, Inc
INDUSTRY
Soroka University Medical Center
OTHER
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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sor517911ctil
Identifier Type: -
Identifier Source: org_study_id
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