Clinical trial NCT02863263: Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer
Official title: A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Keywords: foam dressing
MedifoamⓇ
BetafoamⓇ
povidone iodine
Lead sponsor: Mundipharma Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged at least 19 years old as of the consent date
2. Pressure ulcer of National Pressure Ulcer Advisory Panel (NPUAP) Stage III at screening
3. Pressure ulcer size of 3-10 cm2 at screening
4. Written consent provided by the subject or representative

Exclusion Criteria:

1. Any study ulcer of NPUAP Stage I, II or IV
2. Diabetic ulcer or venous ulcer (or stasis ulcer)
3. Past history of surgical treatment within 1 year or irradiation at the target pressure ulcer within 1 year
4. Hypersensitivity reaction to this product or povidone iodine
5. Hyperthyroidism or thyroid disorder requiring drug treatment
6. Signs of a current underlying systemic infection (sepsis/bacterial infection/tuberculosis) or cellulitis or osteomyelitis
7. Type 1 diabetes
8. Current malnutrition
9. Heavy smoker: Current smoking level of ≥1 pack (20 cigarettes)/day of tobacco
10. Drug or alcohol addiction
11. Requirement of immune-suppressants during the study, or current chemotherapy or radiotherapy
12. Application of other investigational product/medical device within 1 month prior to the investigational device application
13. Pregnant or breast-feeding women
14. Other renal, hepatic, neurological or immunological disorder that may interfere with the wound healing process, at the discretion of the Investigator

Primary outcomes:
measure: Number of Patients With Complete Healing of Ulcer Within 12 Weeks
timeFrame: 12 weeks
measure: Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline
timeFrame: 12 weeks
measure: Pressure Ulcer Size Measured Using A Ruler at Week 12
timeFrame: Week 12 (Or Last Observation Carried Forward)
Secondary outcomes:
measure: Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12
timeFrame: Week 12 (Or Last Observation Carried Forward)
measure: Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
timeFrame: 12 weeks
measure: Number of Patients Achieving Early Study Completion Due to Complete Healing
timeFrame: 12 weeks
measure: Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)
timeFrame: 12 weeks
Other outcomes:
measure: Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer
timeFrame: 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Mundipharma Singapore Holding Pte. Limited
name: Harsha Arumugam
role: STUDY_DIRECTOR
References: