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

ConvaTec Inc.54 enrolled

Overview

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Surgical Wound Trauma-related Wound

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Boston Medical Center

Boston, Massachusetts, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

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

Time frame: 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.

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

Time frame: 4 weeks