Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery (AWBAT-D)

Aubrey

Status: Unknown

Conditions: Treatment of Donor Site Burns

Treatments: Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964470

#AW-101008MC-DS

Details and patient eligibility

About

The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.

Full description

The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery.

Primary Study Goals:

• To compare the rate of healing of donor sites.

• To compare patient reported perception of pain

• To compare the potential clinical complication rates of:

  • non-adherence,
  • seroma
  • hematoma
  • infection

Secondary Study Goal:

• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Burn wounds measuring 1% - 30% TBSA requiring skin grafting
• Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen

Exclusion criteria

• Ventilator dependence
• Pregnancy /Lactation
• Mechanism of injury was electrical, chemical or frostbite
• Co-morbidity which may compromise healing
• Known allergy to porcine or porcine products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)