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Completed

NCT Number: NCT00371215

Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

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Key information

Conditions

Surgical Hemostasis

Age range

2 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Richard M. Fairbanks Burn Center, Wishard Hospital

Indianapolis, Indiana, 46202, United States

About this study

This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury

Exclusion criteria

  • Known antibodies or hypersensitivity to thrombin or other coagulation factors

Treatment and study plan

rThrombin

Biological

1000 U/mL applied topically

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: Up to day 29

Secondary outcomes

  1. The incidence and grade of clinical laboratory abnormalities

    Time frame: Up to day 29

  2. The incidence of anti-rThrombin product antibodies

    Time frame: Up to day 29

  3. The incidence of hemostasis

    Time frame: Up to 20 minutes

  4. The percentage of graft take

    Time frame: Up to day 29

  5. The incidence of re-grafting

    Time frame: Up to day 29

Sponsors and collaborators

Lead sponsor

ZymoGenetics

Industry

Registry information

Official study title

A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 1, 2006
Registry last updated
Mar 9, 2009

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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