Expired Study
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Lubbock, Texas 79410


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.


Study summary:

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.


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.


NCT ID:

NCT01319097


Primary Contact:

Principal Investigator
Randall D Wolcott, M.D.
Southwest Regional Wound Care Center


Backup Contact:

N/A


Location Contact:

Lubbock, Texas 79410
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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