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

Launched by CONVATEC INC. · Nov 18, 2022

Keywords

ClinConnect Summary

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 for up to 4 weeks

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion criteria:
• • 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