A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Number of Patients With Complete Healing of Ulcer Within 12 Weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Foam Dressing (Device)
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.
Intervention: Foam Dressing with Povidone Iodine (Device)
Outcomes
Primary Outcomes
Number of Patients With Complete Healing of Ulcer Within 12 Weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12(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(12 weeks)
- Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)(12 weeks)