An interventional study of ConvaFoam in Surgical Wound and Trauma-related Wound, sponsored by ConvaTec Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by ConvaTec Inc. · Not applicable, Interventional, and Treatment
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
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
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 54 is close to the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →ConvaTec Inc. is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
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Exclusion criteria:
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
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
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
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
Plan to share: No
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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ConvaTec Inc.