An interventional study of Foam Dressing and Foam Dressing with Povidone Iodine in Pressure Ulcer, sponsored by Mundipharma Pte Ltd.. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Mundipharma Pte Ltd. · Not applicable, Interventional, and Supportive care
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.
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.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 5 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Mundipharma Pte Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 on its own. Subjects are randomised to one of 2 arms.
Also known as: Brand name: MedifoamⓇ
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Ⓡ
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12 (Or Last Observation Carried Forward)
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
Time frame: Week 12 (Or Last Observation Carried Forward)
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
| Milestone | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Started | 3 | 2 |
| Completed | 2 | 1 |
| Not completed | 1 | 1 |
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
| Participants | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Number of Patients With Complete Healing of Ulcer Within 12 Weeks | 0 | 0 |
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
No measurements were reported for this outcome.
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.
| cm2 | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Pressure Ulcer Size Measured Using A Ruler at Week 12 | 5.05 (1.0 to 9.1) | 2.8 (0.5 to 5.1) |
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
| score on a scale | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12 | 8 (5 to 11) | 7 (4 to 10) |
| participants | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week | 3 | 2 |
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
| Participants | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Number of Patients Achieving Early Study Completion Due to Complete Healing | 0 | 0 |
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.
| Participants | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC) | 0 | 0 |
Examples of these local events are erythema, edema, itching, flare and rash.
| local adverse events | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer | 1 | 0 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Foam Dressing | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Foam Dressing With Povidone Iodine | 1/2 (50%) | 1/2 (50%) | 0/2 (0%) |
| Event | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 0/3 | 1/2 |
| Event | Foam Dressing | Foam Dressing With Povidone Iodine |
|---|---|---|
| PyrexiaGeneral disorders | 2/3 | 0/2 |
| ErythemaSkin and subcutaneous tissue disorders | 1/3 | 0/2 |
| Alanine aminotransferase increasedInvestigations | 1/3 | 0/2 |
| Aspartate aminotransferase increasedInvestigations | 1/3 | 0/2 |
| ConstipationGastrointestinal disorders | 1/3 | 0/2 |
| Decubitus ulcerSkin and subcutaneous tissue disorders | 1/3 | 0/2 |
| DeliriumPsychiatric disorders | 1/3 | 0/2 |
| DizzinessNervous system disorders | 1/3 | 0/2 |
| HypotensionVascular disorders | 1/3 | 0/2 |
| MiliariaSkin and subcutaneous tissue disorders | 1/3 | 0/2 |
| Age, Categorical(Participants) | Foam Dressing | Foam Dressing With Povidone Iodine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Foam Dressing | Foam Dressing With Povidone Iodine | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Foam Dressing | Foam Dressing With Povidone Iodine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Foam Dressing | Foam Dressing With Povidone Iodine | Total |
|---|---|---|---|
| South Korea | 3 | 2 | 5 |
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