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

Prospective, Multicenter, Observational Study to Evaluate the Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing

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.

Study Overview

• Status: Completed
• Conditions: Wounds

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United Kingdom
  • Rhondda Cynon Taf
    • Ynysmaerdy, Rhondda Cynon Taf, United Kingdom, CF728UX
      • Welsh wound Innovation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with superficial wounds of any etiology, that are treated at outpatients' clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with superficial wounds; A cohort of 50 patients with superficial wounds of any etiology (see inclusion criteria), who need advanced wound care treatment in any case, will be observed over a period of 14 days; the exact duration for each patient depends upon the investigator's assessment. The observation consists of an initial visit, at least one dressing change after max. 7 days and a final visit. Patients will be treated with the CE-marked wound care product. This product is already in general use in the Netherlands and Germany. It is a sterile, bacteria-binding, super-absorbent wound dressing. Apart from the predefined study visits, daily dressing changes in accordance with daily clinical practice are possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).	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.	14 days
Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF)	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.	14 days

Collaborators and Investigators

• Sponsor: BSN Medical GmbH
• Investigators: Principal Investigator: Nicky Ivins, Welsh wound Innovation Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: C1438