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Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

NCT ID: NCT00137215

Last Updated: 2008-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Burns

Keywords

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burns donor site care Silverlon dressing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Silverlon

Intervention Type DEVICE

dressing for donor site mamagement

Interventions

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Silverlon

dressing for donor site mamagement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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USAISR

Principal Investigators

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Michael Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

US Army Institute of Surgical Research

Steven E Wolf, MD

Role: STUDY_DIRECTOR

US Army Institute of Surgical Research

Locations

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US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15091147 (View on PubMed)

Other Identifiers

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H-04-018

Identifier Type: -

Identifier Source: org_study_id