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Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

This study has been completed.
Sponsor:
Collaborator:
Sorbion Aktiengesellschaft, Germany
Information provided by (Responsible Party):
Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT01319097
First received: March 9, 2011
Last updated: September 7, 2011
Last verified: September 2011

March 9, 2011
September 7, 2011
April 2010
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01319097 on ClinicalTrials.gov Archive Site
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
Efficacy [ 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
Not Provided
Not Provided
 
Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pressure Ulcers
Other: Sorbion Sachet S
Dressing is indicated for moderately to heavily exuding wounds.
Other Name: Sorbion Sachet S
Sorbion Sachet S
Subject will evaluate Sorbion Sachet S dressing for 4 weeks.
Intervention: Other: Sorbion Sachet S
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject > 18 years.
  • Subject is attending SW Wound Care Center
  • Subject has a wound not smaller than 1cm2
  • Subject has a wound not larger than 14cm X 23cm
  • Subject has a moderately to highly exudative pressure ulcer that would be indicated for treatment with sorbion sachet S
  • Subject or subject's legally authorized representative is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrollment.
  • Subject is willing and able to comply with all specified care and visit requirements.

Exclusion Criteria:

  • Subject has a lesion that does not meet the inclusion criteria.
  • Subject has a pressure ulcer that contains areas of undermined tissue.
  • Subject refuses to participate in the study.
  • Subject is participating in another clinical study.
  • Subject already participates in this study with one wound (only one wound per subject is allowed)
  • Subject has known sensitivity to the trial product or any of its compounds.
  • Subject is expected to be non-compliant.
  • Subject uses therapy known to be immunocompromising such as systemic anti cancer drugs and/or systemic corticosteroids.
  • Subject suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS.
  • Subject's lesion is a primary skin cancer.
  • Subject's lesion is the manifestation of a metastasis.
  • Subject is pregnant.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01319097
56-RW-017
No
Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
Sorbion Aktiengesellschaft, Germany
Principal Investigator: Randall D Wolcott, M.D. Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP