Back to resultsEfficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer
Primary Purpose
Pressure Ulcer
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Foam Dressing
Foam Dressing with Povidone Iodine
Sponsored by
About this trial
This is an interventional supportive care trial for Pressure Ulcer focused on measuring foam dressing, MedifoamⓇ, BetafoamⓇ, povidone iodine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Foam Dressing
Foam Dressing with Povidone Iodine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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 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.
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.
Secondary Outcome Measures
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
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863263
Brief Title
Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer
Official Title
A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in meeting recruitment target
Study Start Date
July 29, 2016 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Pte Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
foam dressing, MedifoamⓇ, BetafoamⓇ, povidone iodine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foam Dressing
Arm Type
Other
Arm Description
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.
Arm Title
Foam Dressing with Povidone Iodine
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Foam Dressing
Other Intervention Name(s)
Brand name: MedifoamⓇ
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Foam Dressing with Povidone Iodine
Other Intervention Name(s)
Brand name: BetafoamⓇ
Intervention Description
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 Outcome Measure Information:
Title
Number of Patients With Complete Healing of Ulcer Within 12 Weeks
Description
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
Title
Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline
Description
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
Title
Pressure Ulcer Size Measured Using A Ruler at Week 12
Description
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)
Secondary Outcome Measure Information:
Title
Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12
Description
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)
Title
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
Time Frame
12 weeks
Title
Number of Patients Achieving Early Study Completion Due to Complete Healing
Description
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
Title
Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)
Description
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
Other Pre-specified Outcome Measures:
Title
Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer
Description
Examples of these local events are erythema, edema, itching, flare and rash.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harsha Arumugam
Organizational Affiliation
Mundipharma Singapore Holding Pte. Limited
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer
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