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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014