Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05632276
Other study ID # WC-22-440
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Recruiting NCT02685761 - Skin Incisions and Wound Complication Rates for C-sections in Obese Women N/A
Completed NCT01297322 - RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT) N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT03193021 - AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID N/A
Not yet recruiting NCT06028854 - Blood Characteristics and Abdominal Emergency Surgery
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT06342479 - Discharge Training for Patients With Intertrochanteric Fracture N/A
Recruiting NCT04994145 - A Post-Market Clinical Investigation on Mepilex Border Post-Op
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A
Completed NCT04596163 - Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery N/A
Completed NCT04036344 - Buddy Relationships in DermatoloGic Excisions for Skin Cancer N/A
Completed NCT05791721 - Effect of Preemptive Etoricoxib and Dexamethasone on Wound Healing and Clinical Parameters After Third Molar Surgery Phase 4
Recruiting NCT06073678 - Photobiomodulation in Palate Wounds: Somatosensorial Evaluation N/A
Completed NCT05252260 - Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty N/A
Withdrawn NCT04053946 - Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC N/A
Recruiting NCT04740775 - LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures N/A