Text Size

Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

This study has been completed.
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00137215
First received: August 25, 2005
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Active Comparator: A 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:

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

Keywords provided by United States Army Institute of Surgical Research:
burns
donor site care
Silverlon dressing

ClinicalTrials.gov processed this record on June 17, 2013