Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Burns Clinical Trial

Official title:

Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137215
• Other study ID #: H-04-018
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: July 24, 2008
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2008
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.

Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.

Description:

At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older; male or female.

• Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities

• Burns do not involve the harvesting area

• Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas

• Scheduled excision and grafting procedures is the first such operation for subject during this hospitalization

• Subject agrees to participate in follow-up evaluations

Exclusion Criteria:

• Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability

• Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)

• Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis.

• Cellulitis or other infection of potential donor site

• Previously harvested donor site

• Subject with greater than 30% TBSA burns

• Subjects with sensitivity to silver or nylon

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Silverlon
dressing for donor site mamagement

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bowler PG, Jones SA, Walker M, Parsons D. Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. J Burn Care Rehabil. 2004 Mar-Apr;25(2):192-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform		14 days	No
Primary	Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform		30-45 days	No
Secondary	Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform		14 days	No