Hemostatic Textile to Control Bleeding at Donor Graft Sites

NCT00855569 | Completed

• 1 other identifier: PREN-101
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

allografting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Stasilon DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the UNC Jaycee Burn Center

You may qualify if:

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

You may not qualify if:

• \< 18 years
• unable to give consent due to mental or emotional instability

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Preston Rich, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: June 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 12, 2017

Record last verified: 2012-06

Locations

US (1)