Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

Pressure Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319097
• Other study ID #: 56-RW-017
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: September 7, 2011
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

Other:
• Sorbion Sachet S
Dressing is indicated for moderately to heavily exuding wounds.

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center	Sorbion Aktiengesellschaft, Germany

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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	1 year	No