Clinical trial NCT05632276: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Trauma-related Wound
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A 4-week device intervention 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
measure: 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
timeFrame: 4 weeks
measure: 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.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Medical Director
name: Kerem Ozer, MD
role: STUDY_CHAIR
References: