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

• Sponsor: Mundipharma Pte Ltd. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02863263
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Device: Foam Dressing; Device: Foam Dressing with Povidone Iodine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer
• Actual Study Start Date: Jul 29, 2016
• Actual Primary Completion Date: Jul 26, 2017
• Actual Study Completion Date: Jul 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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; 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.; Other Names: Brand name: MedifoamⓇ
Other: 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.	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 own. Subjects are randomised to one of 2 arms.; Other Names: Brand name: BetafoamⓇ

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Secondary Outcome Measures

1. 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

2. Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week [12 weeks]

3. 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.

4. 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.

Other Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Mundipharma Pte Ltd.

Investigators

• Study Director: Harsha Arumugam, Mundipharma Singapore Holding Pte. Limited

Study Documents (Full-Text)

• Study Protocol - Jun 15, 2017
• Statistical Analysis Plan - Oct 27, 2016

More Information

Publications

None provided.

• Responsible Party: Mundipharma Pte Ltd.
• ClinicalTrials.gov Identifier: NCT02863263
• Other Study ID Numbers: BTF16-AP-401
• First Posted: Aug 11, 2016
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mundipharma Pte Ltd.: foam dressing; MedifoamⓇ; BetafoamⓇ; povidone iodine
• Additional relevant MeSH terms: Pressure Ulcer; Ulcer; Povidone-Iodine; Povidone

Study Results

Participant Flow

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Period Title: Overall Study
STARTED	3	2
COMPLETED	2	1
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine	Total
Arm/Group 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. 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.	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.	Total of all reporting groups
Overall Participants	3	2	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 33.3%	0 0%	1 20%
>=65 years	2 66.7%	2 100%	4 80%
Sex: Female, Male (Count of Participants)
Female	3 100%	2 100%	5 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
South Korea	3 100%	2 100%	5 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Count of Participants [Participants]	0 0%	0 0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

There is no analysis and result for this outcome measure as none of the subjects achieved complete healing of ulcer within 12 weeks.

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	0	0

3. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Median (Full Range) [cm2]	5.05	2.8

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Median (Full Range) [score on a scale]	8	7

5. Secondary Outcome

Title	Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Number [participants]	3 100%	2 100%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Count of Participants [Participants]	0 0%	0 0%

8. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Foam Dressing	Foam Dressing With Povidone Iodine
Arm/Group 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. 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.	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.
Measure Participants	3	2
Number [local adverse events]	1	0

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Arm/Group Title	Foam Dressing		Foam Dressing With Povidone Iodine
Arm/Group 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. 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.		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.
All Cause Mortality
	Foam Dressing		Foam Dressing With Povidone Iodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/2 (50%)
Serious Adverse Events
	Foam Dressing		Foam Dressing With Povidone Iodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/2 (50%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	0/3 (0%)	0	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	Foam Dressing		Foam Dressing With Povidone Iodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		0/2 (0%)
Gastrointestinal disorders
Constipation	1/3 (33.3%)	1	0/2 (0%)	0
General disorders
Pyrexia	2/3 (66.7%)	3	0/2 (0%)	0
Infections and infestations
Pyuria	1/3 (33.3%)	1	0/2 (0%)	0
Injury, poisoning and procedural complications
Skin abrasion	1/3 (33.3%)	1	0/2 (0%)	0
Investigations
Alanine aminotransferase increased	1/3 (33.3%)	1	0/2 (0%)	0
Aspartate aminotransferase increased	1/3 (33.3%)	1	0/2 (0%)	0
Urine output decreased	1/3 (33.3%)	1	0/2 (0%)	0
Nervous system disorders
Dizziness	1/3 (33.3%)	1	0/2 (0%)	0
Psychiatric disorders
Delirium	1/3 (33.3%)	1	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	1/3 (33.3%)	1	0/2 (0%)	0
Decubitus ulcer	1/3 (33.3%)	1	0/2 (0%)	0
Miliaria	1/3 (33.3%)	1	0/2 (0%)	0
Vascular disorders
Hypotension	1/3 (33.3%)	1	0/2 (0%)	0

Limitations/Caveats

Difficulties in meeting recruitment target led to termination of the trial. Statistical analysis was not performed due to insufficient number of subjects enrolled.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Mundipharma Pte Ltd is owner of the data. No Investigator may publish the results of this study without prior approval from Mundipharma Pte Ltd.