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Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137215
First Posted: August 29, 2005
Last Update Posted: July 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
United States Army Institute of Surgical Research
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Resource links provided by NLM:


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 ]
  • 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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 25, 2005
First Posted: August 29, 2005
Last Update Posted: July 28, 2008
Last Verified: July 2008

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