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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662218
• Other study ID #: C1438
• Status: Completed
• Phase: N/A
• First received: January 8, 2016
• Last updated: June 20, 2017
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: BSN Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds
• Wounds and Injuries

Locations

Country	Name	City	State
United Kingdom	Welsh Wound Innovation Centre	Ynysmaerdy	Rhondda Cynon Taf

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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