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

Pressure Ulcer Clinical Trial

Official title:

A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02863263
• Other study ID #: BTF16-AP-401
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2016
• Est. completion date: July 26, 2017

Study information

• Verified date: May 2019
• Source: Mundipharma Pte Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 26, 2017
• Est. primary completion date: July 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Pte Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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.	12 weeks
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.	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.	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	Week 12 (Or Last Observation Carried Forward)
Secondary	Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week		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.	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.	12 weeks