A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds

Completed · Not applicable

Conditions studied: Surgical Wound, Trauma-related Wound

In brief

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds

Key facts

Study ID

NCT05632276

Run by

ConvaTec Inc.

People needed

54

Starts

2023-06-08

Expected to finish

2024-03-13

Last updated by the study team

2024-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18 years and over
• Patients able and willing to provide informed consent
• Patients with Surgical wounds including incisional wounds including laparoscopic
• wounds and surgical wounds healing by secondary intention.
• Patients with Traumatic wounds
• Patients must be willing to attend visits as per schedule in protocol

You may not qualify if…

• Patients with known allergies to any of the materials used in the dressing
• Patients who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions.
• Patients, who in the opinion of the investigator, is considered unsuitable for any other reason
• Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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