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

Not Applicable

Terminated

Interventions: Device: Foam Dressing
Device: Foam Dressing with Povidone Iodine

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Foam Dressing	Foam Dressing	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.
Foam Dressing with Povidone Iodine	Foam Dressing with Povidone Iodine	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Complete Healing of Ulcer Within 12 Weeks	12 weeks	Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline	12 weeks	Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Pressure Ulcer Size Measured Using A Ruler at Week 12	Week 12 (Or Last Observation Carried Forward)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week	12 weeks
Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12	Week 12 (Or Last Observation Carried Forward)	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
Number of Patients Achieving Early Study Completion Due to Complete Healing	12 weeks	Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)	12 weeks	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.