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

NCT02863263 | Terminated Results

• 1 other identifier: BTF16-AP-401
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

foam dressing; MedifoamⓇ; BetafoamⓇ; povidone iodine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Other Outcomes (1)

• Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer

  12 weeks

Study Arms (2)

Foam Dressing

OTHER

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

Foam Dressing with Povidone Iodine

OTHER

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

Interventions

Foam Dressing DEVICE

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.

Also known as: Brand name: MedifoamⓇ

Foam Dressing

Foam Dressing with Povidone Iodine DEVICE

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.

Also known as: Brand name: BetafoamⓇ

Foam Dressing with Povidone Iodine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mundipharma Pte Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Difficulties in meeting recruitment target led to termination of the trial. Statistical analysis was not performed due to insufficient number of subjects enrolled.

Results Point of Contact

• Title: Valerie Anne Leck
• Organization: Mundipharma Singapore Holding Pte. Limited

info.rma@mundipharma.com.sg

+65 6511 1165

Study Officials

• Harsha Arumugam

  Mundipharma Singapore Holding Pte. Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: July 29, 2016
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)