NCT02863263

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

Terminated NA Results posted Last updated 15 May 2019

What this trial tests

NA trial testing Foam Dressing in Pressure Ulcer in 5 participants. Terminated before completion.

Timeline

29 July 2016

Primary endpoint
26 July 2017

26 July 2017

Quick facts

Lead sponsor	Mundipharma Pte Ltd.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	5
Start date	29 July 2016
Primary completion	26 July 2017
Estimated completion	26 July 2017
Sites	1 location across South Korea

Drugs / interventions tested

• Foam Dressing
• Foam Dressing with Povidone Iodine

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →

Sponsor

Mundipharma Pte Ltd.

Who can join

19 and older, any sex, with Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Complete Healing of Ulcer Within 12 Weeks Primary · 12 weeks

Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.

Group	Value	95% CI
Foam Dressing	0
Foam Dressing With Povidone Iodine	0

Pressure Ulcer Size Measured Using A Ruler at Week 12 Primary · 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.

Group	Value	95% CI
Foam Dressing	5.05	1.0 – 9.1
Foam Dressing With Povidone Iodine	2.8	0.5 – 5.1

Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12 Secondary · 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

Group	Value	95% CI
Foam Dressing	8	5 – 11
Foam Dressing With Povidone Iodine	7	4 – 10

Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week Secondary · 12 weeks

Group	Value	95% CI
Foam Dressing	3
Foam Dressing With Povidone Iodine	2

Number of Patients Achieving Early Study Completion Due to Complete Healing Secondary · 12 weeks

Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.

Group	Value	95% CI
Foam Dressing	0
Foam Dressing With Povidone Iodine	0

Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC) Secondary · 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.

Group	Value	95% CI
Foam Dressing	0
Foam Dressing With Povidone Iodine	0

Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer Secondary · 12 weeks

Examples of these local events are erythema, edema, itching, flare and rash.

Group	Value	95% CI
Foam Dressing	1
Foam Dressing With Povidone Iodine	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Foam Dressing

Serious: 0/3 (0%)

Deaths: 0/3

Foam Dressing With Povidone Iodine

Serious: 1/2 (50%)

Deaths: 1/2

Serious adverse events (1 terms)

Reaction	System	Foam Dressing	Foam Dressing With Povidon…
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Foam Dressing	Foam Dressing With Povidon…
Pyrexia	General disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Constipation	Gastrointestinal disorders	—	—
Decubitus ulcer	Skin and subcutaneous tissue disorders	—	—
Delirium	Psychiatric disorders	—	—
Dizziness	Nervous system disorders	—	—
Hypotension	Vascular disorders	—	—
Miliaria	Skin and subcutaneous tissue disorders	—	—
Pyuria	Infections and infestations	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—
Urine output decreased	Investigations	—	—

Most-reported serious reactions: Pneumonia aspiration.

Data from ClinicalTrials.gov NCT02863263 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.