Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing
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|ClinicalTrials.gov Identifier: NCT01319097|
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : September 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers||Other: Sorbion Sachet S||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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.
- 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 ]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 ]Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s
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): NCT01319097
|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|