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

Surgical Wound Clinical Trial

— MATILDA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632276
• Other study ID #: WC-22-440
• Status: Completed
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: March 13, 2024

Study information

• Verified date: April 2024
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Surgical Wound
• Trauma-related Wound
• Wounds and Injuries

Intervention

Device:
• ConvaFoam
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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	4 weeks
Secondary	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.	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	4 weeks