Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing
This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study of Evaluate the Effect of Sorbion Sachet S Wound Dressing on Soft Tissue Edema and Wound Bioburden in Moderately to Highly Exuding Pressure Ulcers|
- The primary objective of this study is to investigate the effect of sachet S reduction on local soft tissue edema (excessive interstitial fluid to a maximum 3cm depth) in pressure ulcers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]To investigate the effect of sachet S reduction on local soft tissue edema in pressure ulcers and the degree to which sachet S influences the wound surface bioburden qualitatively and quantitatively.
- The secondary objectives are to further investigate whether sorbion sachet s [ Time Frame: 1 year ] [ Designated as safety issue: No ]Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s
|Study Start Date:||April 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Sorbion Sachet S
Subject will evaluate Sorbion Sachet S dressing for 4 weeks.
Other: Sorbion Sachet S
Dressing is indicated for moderately to heavily exuding wounds.
Other Name: Sorbion Sachet S
This study is aimed at the participation of subject with moderately to highly exuding pressure ulcers. Each Subject is expected to participate for a period of 4 weeks or until reepithelization, which occurs first.
|United States, Texas|
|Southwest Regional Wound Care Center|
|Lubbock, Texas, United States, 79410|
|Principal Investigator:||Randall D Wolcott, M.D.||Southwest Regional Wound Care Center|