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

Not Applicable

Completed

Brief 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

Detailed Description: 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

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
ConvaFoam dressings	ConvaFoam	Participants wounds will be assessed and will be allocated ConvaFoam Border, Silicone or Non-Adhesive dressing based upon the investigator's clinical judgment. participants will receive a dressing as part of a protocol of care for up to a period of 4 weeks

Primary Outcome Measures

Name	Time	Method
Demonstrate the efficacy of ConvaFoam ™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU	4 weeks	The efficacy will be measured by the dressings ability to manage exudate as demonstrated by: Lack of strikethrough Maintenance or improvement of peri-wound skin

Secondary Outcome Measures

Name	Time	Method
Demonstrate the performance of ConvaFoam™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU	4 weeks	Performance will be measured by: Wound healing as anticipated by primary or secondary intention Wear time Atraumatic removal Pain (pre application during application and on removal) Dressing comfort (patient satisfied with dressing comfort, able to resume activities of daily living) Ease of use Ease of removal Health Care Practitioner satisfaction
Demonstrate the safety of, ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of the indicated acute wounds when used in accordance with the IFU.	4 weeks	Safety will be measured by: Adverse reaction (including wound complications such as maceration, bleeding, blistering / protection of peri-wound edges / peri-wound skin integrity) Device Malfunctions

Locations (2): Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
Wake Forest School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States

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