Skip to main content
OpenTrials
Completed

NCT Number: NCT01319097

Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorbion Sachet S

Other

Dressing is indicated for moderately to heavily exuding wounds.

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.

    Time frame: 1 year

    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.

Secondary outcomes

  1. The secondary objectives are to further investigate whether sorbion sachet s

    Time frame: 1 year

    Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Collaborators

  • Sorbion Aktiengesellschaft, Germany

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 21, 2011
Registry last updated
Sep 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.