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

NCT05632276 | Completed FDA Device

• 1 other identifier: WC-22-440
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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

Conditions

Surgical Wound; Trauma-related Wound

Outcome Measures

Primary Outcomes (1)

• 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

  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

  4 weeks

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

ConvaFoam dressings

OTHER

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

Device: ConvaFoam

Interventions

ConvaFoam DEVICE

ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. All participants will be assigned a dressing based upon clinical judgement for a maximum of 4 weeks with weekly assessments and dressing changes

Also known as: ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive

ConvaFoam dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02218, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kerem Ozer, MD

  Medical Director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 30, 2022
• Study Start: June 8, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)