Clinical trial NCT01319097: Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Keywords: Reduction on local soft tissue edema
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
Collaborators: name: Sorbion Aktiengesellschaft, Germany
First posted: 2011-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: The secondary objectives are to further investigate whether sorbion sachet s
timeFrame: 1 year
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall D Wolcott, M.D.
role: PRINCIPAL_INVESTIGATOR
References: