Back to resultsStudy to Evaluate the Effect of Sorbion Sachet S Wound Dressing
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sorbion Sachet S
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers focused on measuring Reduction on local soft tissue edema
Eligibility 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.
Sites / Locations
- Southwest Regional Wound Care Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sorbion Sachet S
Arm Description
Subject will evaluate Sorbion Sachet S dressing for 4 weeks.
Outcomes
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.
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
Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s
Full Information
NCT ID
NCT01319097
First Posted
March 9, 2011
Last Updated
September 7, 2011
Sponsor
Southwest Regional Wound Care Center
Collaborators
Sorbion Aktiengesellschaft, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01319097
Brief Title
Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southwest Regional Wound Care Center
Collaborators
Sorbion Aktiengesellschaft, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Reduction on local soft tissue edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorbion Sachet S
Arm Type
Other
Arm Description
Subject will evaluate Sorbion Sachet S dressing for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Sorbion Sachet S
Intervention Description
Dressing is indicated for moderately to heavily exuding wounds.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The secondary objectives are to further investigate whether sorbion sachet s
Description
Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall D Wolcott, M.D.
Organizational Affiliation
Southwest Regional Wound Care Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Regional Wound Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing
We'll reach out to this number within 24 hrs