Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

Completed · Not applicable

Conditions studied: Pressure Ulcers

In brief

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.

Key facts

Study ID

NCT01319097

Run by

Southwest Regional Wound Care Center

People needed

5

Starts

2010-04-01

Expected to finish

2011-08-01

Last updated by the study team

2011-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southwest Regional Wound Care Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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