A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.

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• Pressure Ulcer 518
• Crush Injuries 125

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 95 is above the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Lead sponsor

ConvaTec Inc. is the lead sponsor of 43 studies on the registry; 6 are open to participants now.

Study arms

• Other
  ConvaFoam dressings

  All participants wounds will be assessed and allocated a dressing based upon the investigator's clinical judgement. They will receive either ConvaFoam Border, Silicone or Non-Adhesive for up to 12 weeks as part of their standard of care

  Device: ConvaFoam

Interventions

• DeviceConvaFoam

  ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks.

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

Primary outcomes

1. To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.

   This will be measured by: Lack of strike through Loss of edge seal/adherence, Dressing leakage/seepage Dislodgement Need for dressing change

   Time frame: 12 weeks

Secondary outcomes

1. To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use

   Performance will be measured by documenting the progress of the wound through a weekly standard wound assessment where progression with be measured by changes to the wound healing status from deteriorating to static, static to improvement or improved to healed

   Time frame: 12 weeks

2. To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use

   As part of the study schedule Health Care Professionals to complete a questionnaire at the end of study to assess: Ease of use Ease of removal ( Atraumatic) Wear time (meets recommended guidelines in IFU)

   Time frame: 12 weeks

3. To measure the performance of ConvaFoam dressings in the management of chronic wounds from a patient perspective when used in accordance with the instructions for use

   As part of the study schedule patients will be asked to complete a quality of life questionnaire on their first and final visit to measure: Dressing comfort ( patient satisfied with dressing comfort and able to resume activities of daily living

   Time frame: 12 weeks

4. To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use

   Any device related adverse events such as wound complications, maceration, blistering, breakdown of peri wound skin edges or changes to skin integrity will be documented and reported as per protocol

   Time frame: 12 weeks

5. To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use

   Any device related adverse events such will be documented and reported as per protocol

   Time frame: 12 weeks

Individual participant data

Plan to share: No