Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

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

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 Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Other: Sorbion Sachet S

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Southwest Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Sorbion Sachet S; Subject will evaluate Sorbion Sachet S dressing for 4 weeks.	Other: Sorbion Sachet S; Dressing is indicated for moderately to heavily exuding wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	To investigate the effect of sachet S reduction on local soft tissue edema in pressure ulcers and the degree to which sachet S influences the wound surface bioburden qualitatively and quantitatively.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary objectives are to further investigate whether sorbion sachet s	Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s	1 year

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center
• Collaborators: Sorbion Aktiengesellschaft, Germany

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (ESTIMATE): March 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 8, 2011
• Last Update Submitted That Met QC Criteria: September 7, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Reduction on local soft tissue edema
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: 56-RW-017