Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pressure Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorbion Sachet S

Subject will evaluate Sorbion Sachet S dressing for 4 weeks.

Group Type OTHER

Sorbion Sachet S

Intervention Type OTHER

Dressing is indicated for moderately to heavily exuding wounds.

Interventions

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Sorbion Sachet S

Dressing is indicated for moderately to heavily exuding wounds.

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No