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

Tracking Information

First Received Date ^ICMJE

March 9, 2011

Last Updated Date

September 7, 2011

Start Date ^ICMJE

April 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01319097 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pressure Ulcers

Intervention ^ICMJE

Other: Sorbion Sachet S

Dressing is indicated for moderately to heavily exuding wounds.

Other Name: Sorbion Sachet S

Study Arm (s)

Sorbion Sachet S

Subject will evaluate Sorbion Sachet S dressing for 4 weeks.

Intervention: Other: Sorbion Sachet S

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01319097

Other Study ID Numbers ^ICMJE

56-RW-017

Has Data Monitoring Committee

Responsible Party

Southwest Regional Wound Care Center

Study Sponsor ^ICMJE

Southwest Regional Wound Care Center

Collaborators ^ICMJE

Sorbion Aktiengesellschaft, Germany

Investigators ^ICMJE

Principal Investigator:

Randall D Wolcott, M.D.

Southwest Regional Wound Care Center

Information Provided By

Southwest Regional Wound Care Center

Verification Date

September 2011

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

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