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

NCT02662218 | Completed

• 1 other identifier: C1438
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (1)

Welsh Wound Innovation Centre

Ynysmaerdy, Rhondda Cynon Taf, CF728UX, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Nicky Ivins

  Welsh Wound Innovation Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 25, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

GB (1)