Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites - Full Text View

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00137215

Purpose

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.

Condition	Intervention
Burns	Device: Silverlon

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study
Official Title:	Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Resource links provided by NLM:

MedlinePlus related topics: Burns

U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:

Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform [ Time Frame: 30-45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Device: Silverlon dressing for donor site mamagement

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137215

Locations

United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234-6315

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:	Michael Albrecht, MD	US Army Institute of Surgical Research
Study Director:	Steven E Wolf, MD	US Army Institute of Surgical Research

More Information

Publications:

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.

Responsible Party:	USAISR ( Leopoldo cancio, COL, MC )
Study ID Numbers:	H-04-018
Study First Received:	August 25, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00137215 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

burns
donor site care
Silverlon dressing

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on September 11, 2009