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

Mundipharma

Status: Terminated

Conditions: Pressure Ulcer

Treatments: Device: Foam Dressing; Device: Foam Dressing with Povidone Iodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02863263

BTF16-AP-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Foam Dressing

Other 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.

Treatment:

Device: Foam Dressing

Foam Dressing with Povidone Iodine

Other 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.

Treatment:

Device: Foam Dressing with Povidone Iodine