MedTrace Logo

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

NCT02863263 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-05-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Pressure Ulcer

Interventions

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.

Sponsors & Collaborators

  • Mundipharma Pte Ltd.

    lead INDUSTRY

Principal Investigators

  • Harsha Arumugam · Mundipharma Singapore Holding Pte. Limited

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-29
Primary Completion
2017-07-26
Completion
2017-07-26

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02863263 on ClinicalTrials.gov