NCT02863263

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Mundipharma Pte Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-07-29
• Primary completion: 2017-07-26
• Completion: 2017-07-26
• First posted: 2016-08-11
• Last updated: 2019-05-15
• Results posted: 2019-05-15

Locations

1 site across 1 country: South Korea