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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Foam Dressing; Device: Foam Dressing with Povidone Iodine

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Foam Dressing; 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.; Other Names: Brand name: MedifoamⓇ
Other: 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.	Device: Foam Dressing with Povidone Iodine; 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.; Other Names: Brand name: BetafoamⓇ

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer	Examples of these local events are erythema, edema, itching, flare and rash.	12 weeks

Collaborators and Investigators

• Sponsor: Mundipharma Pte Ltd.
• Investigators: Study Director: Harsha Arumugam, Mundipharma Singapore Holding Pte. Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2016
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 12, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: povidone iodine; foam dressing; MedifoamⓇ; BetafoamⓇ
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: BTF16-AP-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No