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

NCT ID: NCT02662218

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BSN Medical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicky Ivins

Role: PRINCIPAL_INVESTIGATOR

Welsh Wound Innovation Centre

Locations

Welsh Wound Innovation Centre

Ynysmaerdy, Rhondda Cynon Taf, United Kingdom

Countries

United Kingdom

Other Identifiers

C1438

Identifier Type: -

Identifier Source: org_study_id