Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

Southwest Regional Wound Care Center

Status

Completed

Conditions

Pressure Ulcers

Treatments

Other: Sorbion Sachet S

Study type

Interventional

Funder types

Other

Identifiers

NCT01319097

56-RW-017

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.