Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

NCT01319097 | Completed

• 1 other identifier: 56-RW-017
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcers

Keywords

Reduction on local soft tissue edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary objectives are to further investigate whether sorbion sachet s

  1 year

Study Arms (1)

Sorbion Sachet S

OTHER

Subject will evaluate Sorbion Sachet S dressing for 4 weeks.

Other: Sorbion Sachet S

Interventions

Sorbion Sachet S OTHER

Dressing is indicated for moderately to heavily exuding wounds.

Sorbion Sachet S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Regional Wound Care Center: lead
• Sorbion Aktiengesellschaft, Germany: collaborator

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Randall D Wolcott, M.D.

  Southwest Regional Wound Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 21, 2011
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

US (1)