Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer

Study Overview
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Brief Summary
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This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm.

Detailed Description
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As the primary objective, the percentage of completely healed patients and the time to complete healing will be assessed after applying the study device, MedifoamⓇ or BetafoamⓇ, for 12 weeks to pressure ulcer patients. In addition, the pressure ulcer size reduction rate over 12 weeks will be evaluated. Patients will make once weekly site visits. There are 14 visits in total, including a screening visit 14 days (maximum) before the baseline visit.

Official Title
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A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: Foam Dressing
* Device: Foam Dressing with Povidone Iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged at least 19 years old as of the consent date Pressure ulcer of National Pressure Ulcer Advisory Panel (NPUAP) Stage III at screening Pressure ulcer size of 3-10 cm2 at screening Written consent provided by the subject or representative Exclusion Criteria: Any study ulcer of NPUAP Stage I, II or IV Diabetic ulcer or venous ulcer (or stasis ulcer) Past history of surgical treatment within 1 year or irradiation at the target pressure ulcer within 1 year Hypersensitivity reaction to this product or povidone iodine Hyperthyroidism or thyroid disorder requiring drug treatment Signs of a current underlying systemic infection (sepsis/bacterial infection/tuberculosis) or cellulitis or osteomyelitis Type 1 diabetes Current malnutrition Heavy smoker: Current smoking level of ≥1 pack (20 cigarettes)/day of tobacco Drug or alcohol addiction Requirement of immune-suppressants during the study, or current chemotherapy or radiotherapy Application of other investigational product/medical device within 1 month prior to the investigational device application Pregnant or breast-feeding women Other renal, hepatic, neurological or immunological disorder that may interfere with the wound healing process, at the discretion of the Investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Foam Dressing<br>Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. | Device: Foam Dressing<br>* The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.<br>* Other names: Brand name: MedifoamⓇ;|
| Other: Foam Dressing with Povidone Iodine<br>Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. | Device: Foam Dressing with Povidone Iodine<br>* The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.<br>* Other names: Brand name: BetafoamⓇ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Complete Healing of Ulcer Within 12 Weeks | Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration. | 12 weeks | 
| Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline | Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration. | 12 weeks | 
| Pressure Ulcer Size Measured Using A Ruler at Week 12 | The ulcer area (for ulcers without re-epithelization) is measured at each visit after foam dressing application. A photograph of the ulcer is taken and a using a ruler (MediRuleⓇ) is used to measure its length and width to obtain the area in cm2. | Week 12 (Or Last Observation Carried Forward) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12 | The PUSH score is measured at alternate visits (2-week intervals) starting from baseline and will be compared against baseline. Minimum score= 0 Maximum score: 17 Higher score: worse outcome | Week 12 (Or Last Observation Carried Forward) | 
| Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week |  | 12 weeks | 
| Number of Patients Achieving Early Study Completion Due to Complete Healing | Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration. | 12 weeks | 
| Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC) | Patients with at least 1 new infection after the foam dressing application at baseline until Visit 14 will be taken into account. Infection is defined as presence of purulent exudates or 2 or more symptoms stated in the CCSC. For patients with existing infection at baseline, infection is defined as the development of an additional symptom or recurrence of the baseline symptom after it was completely healed. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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foam dressing, MedifoamⓇ, BetafoamⓇ, povidone iodine