Pressure Ulcer
Conditions
Keywords
foam dressing, MedifoamⓇ, BetafoamⓇ, povidone iodine
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.
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.
Interventions
DEVICEFoam 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.
DEVICEFoam 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.
Sponsors
Mundipharma Pte Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Ulcer Size Measured Using A Ruler at Week 12 | 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. |
| Number of Patients With Complete Healing of Ulcer Within 12 Weeks | 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 to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline | 12 weeks | Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Early Study Completion Due to Complete Healing | 12 weeks | Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration. |
| Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC) | 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. |
| Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12 | 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 |
| Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week | 12 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer | 12 weeks | Examples of these local events are erythema, edema, itching, flare and rash. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Foam Dressing With Povidone Iodine | Total | Foam Dressing |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment South Korea | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 2 |
| other Total, other adverse events | 3 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 1 / 2 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foam Dressing | Number of Patients With Complete Healing of Ulcer Within 12 Weeks | 0 Participants |
| Foam Dressing With Povidone Iodine | Number of Patients With Complete Healing of Ulcer Within 12 Weeks | 0 Participants |
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.
Time frame: Week 12 (Or Last Observation Carried Forward)
Population: Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foam Dressing | Pressure Ulcer Size Measured Using A Ruler at Week 12 | 5.05 cm2 |
| Foam Dressing With Povidone Iodine | Pressure Ulcer Size Measured Using A Ruler at Week 12 | 2.8 cm2 |
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.
Time frame: 12 weeks
Population: There is no analysis and result for this outcome measure as none of the subjects achieved complete healing of ulcer within 12 weeks.
Secondary
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foam Dressing | Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week | 3 participants |
| Foam Dressing With Povidone Iodine | Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week | 2 participants |
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foam Dressing | Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC) | 0 Participants |
| Foam Dressing With Povidone Iodine | Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC) | 0 Participants |
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foam Dressing | Number of Patients Achieving Early Study Completion Due to Complete Healing | 0 Participants |
| Foam Dressing With Povidone Iodine | Number of Patients Achieving Early Study Completion Due to Complete Healing | 0 Participants |
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
Time frame: Week 12 (Or Last Observation Carried Forward)
Population: Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foam Dressing | Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12 | 8 score on a scale |
| Foam Dressing With Povidone Iodine | Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12 | 7 score on a scale |
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foam Dressing | Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer | 1 local adverse events |
| Foam Dressing With Povidone Iodine | Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer | 0 local adverse events |