Stasilon: Hemostatic Textile to Control Bleeding at Donor Graft Sites

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00855569

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: Stasilon

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1 Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made	Device: Stasilon Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.

Arm

Intervention/Treatment

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

Device: Stasilon

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

Outcome Measures

Primary Outcome Measures

To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding. [At the time of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Carolina Jaycee Burn Center	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator: Preston Rich, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00855569

Other Study ID Numbers:

PREN-101

First Posted:

Mar 4, 2009

Last Update Posted:

Dec 12, 2017

Last Verified:

Jun 1, 2012

Keywords provided by University of North Carolina, Chapel Hill

allografting

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Dec 12, 2017