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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
History of Changes
  Purpose

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.


Condition Intervention
Pressure Ulcers
 Other: Sorbion Sachet S

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 5
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319097

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Sorbion Aktiengesellschaft, Germany
Investigators
Principal Investigator: Randall D Wolcott, M.D. Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT01319097     History of Changes
Other Study ID Numbers: 56-RW-017
Study First Received: March 9, 2011
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
Reduction on local soft tissue edema

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013