Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

Sponsor

United States Army Institute of Surgical Research (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00137215

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Device: Silverlon	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Device: Silverlon dressing for donor site mamagement

Arm

Intervention/Treatment

Active Comparator: A

Device: Silverlon

dressing for donor site mamagement

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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