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Completed

NCT Number: NCT00855569

Hemostatic Textile to Control Bleeding at Donor Graft Sites

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stasilon

Device

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

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.

    Time frame: At the time of surgery

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: Stasilon

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 4, 2009
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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