Observational Study of 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.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Welsh Wound Innovation Centre

Ynysmaerdy, Rhondda Cynon Taf, CF728UX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

BSN Medical GmbH

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 25, 2016
Registry last updated: Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed