Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

NCT00137215 | Completed

• 1 other identifier: H-04-018
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burns

Keywords

burns; donor site care; Silverlon dressing

Outcome Measures

Primary Outcomes (2)

• Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform

  14 days

• 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

Secondary Outcomes (1)

• Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform

  14 days

Study Arms (1)

A

ACTIVE COMPARATOR

Device: Silverlon

Interventions

Silverlon DEVICE

dressing for donor site mamagement

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Institute of Surgical Research: lead

Study Sites (1)

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234-6315, United States

Location

Related 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. doi: 10.1097/01.bcr.0000112331.72232.1b.

  PMID: 15091147 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michael Albrecht, MD

  US Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

• Steven E Wolf, MD

  US Army Institute of Surgical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: January 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 28, 2008

Record last verified: 2008-07

Locations

US (1)