Observational Study of Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing

Completed

• Conditions: Wounds

• Registration Number: NCT02662218
• Lead Sponsor: BSN Medical GmbH

Brief Summary

This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Study Start: 2016-07
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Men and women ≥ 18 years old

• Written informed consent after patient education to participate in the study

• Superficial wounds of any etiology affecting only epidermis and dermis layers

• Maximum wound size: 6 x 16cm / 6 x 6cm

• Wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following:

  • Wounds assessed as critically colonized with malodour, abnormal tissue or absence of viable tissue, excessive or increased serous exudate, possible extension of wound dimensions and no sign of a healing process and/or
  • Wounds with one or more historical episodes of topical infection and/or
  • Wounds assessed as at a high risk of infection on other grounds by the investigator.

• Superficial wounds with high levels of exudate

Exclusion Criteria

• Not willing to sign or incapable of signing an informed consent form
• Known allergy or sensitivity to one of the dressing components
• Pregnancy or lactation
• Subject is participating in another clinical study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).	14 days	Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF)	14 days	Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.

Trial Locations

Locations (1)

Welsh Wound Innovation Centre; 🇬🇧 Ynysmaerdy, Rhondda Cynon Taf, United Kingdom