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

NCT ID: NCT02863263

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2017-07-26

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Foam Dressing

Intervention Type: DEVICE

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

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.

Group Type: OTHER

Foam Dressing with Povidone Iodine

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Brand name: MedifoamⓇ; Brand name: BetafoamⓇ

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Pte Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harsha Arumugam

Role: STUDY_DIRECTOR

Mundipharma Singapore Holding Pte. Limited

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BTF16-AP-401

Identifier Type: -

Identifier Source: org_study_id