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Difficulties in meeting recruitment target
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harsha Arumugam | Mundipharma Singapore Holding Pte. Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks
Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | The causal relationship was assessed to be unrelated to the investigational device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | Systematic Assessment |
Difficulties in meeting recruitment target led to termination of the trial. Statistical analysis was not performed due to insufficient number of subjects enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Anne Leck | Mundipharma Singapore Holding Pte. Limited | +65 6511 1165 | info.rma@mundipharma.com.sg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2017 | May 28, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2016 | May 29, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| 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. |
|
|
| 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 |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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. 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. |
|
|
| Primary | 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. | There is no analysis and result for this outcome measure as none of the subjects achieved complete healing of ulcer within 12 weeks. | Posted | 12 weeks |
|
|
| Primary | 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. | Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination. | Posted | Median | Full Range | cm2 | Week 12 (Or Last Observation Carried Forward) |
|
|
|
| Secondary | 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 | Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination. | Posted | Median | Full Range | score on a scale | Week 12 (Or Last Observation Carried Forward) |
|
|
|
| Secondary | Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week | The original Outcome Measure was frequency of additional dressing change. However, statistical analysis for this outcome measure was not performed due to low enrolment and early study termination. Therefore, the number of participants with dressing changes of more than twice weekly is reported instead. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Number | local adverse events | 12 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 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. 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. | 1 | 2 | 1 | 2 | 0 | 2 |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pyuria | Infections and infestations | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urine output decreased | Investigations | Systematic Assessment |
|
Mundipharma Pte Ltd is owner of the data. No Investigator may publish the results of this study without prior approval from Mundipharma Pte Ltd.