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Hemostatic Textile to Control Bleeding at Donor Graft Sites

NCT ID: NCT00855569

Last Updated: 2017-12-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

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The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.

Detailed Description

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Conditions

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Wounds

Keywords

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allografting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made

Stasilon

Intervention Type DEVICE

Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.

Interventions

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Stasilon

Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>/= 18 years old
* burn injury requiring allografting from donor site

Exclusion Criteria

* \< 18 years
* unable to give consent due to mental or emotional instability
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Preston Rich, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PREN-101

Identifier Type: -

Identifier Source: org_study_id