NCT01548443

Study to Evaluate Clinical Efficacy and Safety of "Medifoam H" in Wound Healing

The Wound Healing Efficacy and Safety of Medifoam H in Patients With Minor, Acute Trauma: a Single-center, Randomized, Active-controlled, Open-label, Phase IV

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The wound healing efficacy and safety of "Medifoam H" in patients with minor, acute trauma. The hypothesis of this study is that using "Medifoam H" dressing for a week is not inferior to using "Duoderm THIN" dressing in wound healing.

Detailed description

This study is single-center, randomized, active-controlled, open-label, Phase IV to evaluate clinical efficacy of wound healing and safety of "Medifoam H" in patients with minor, acute trauma. 33 patients of treatment group and 33 patients of control group, total 66 patients will be enrolled to this study. Every patient will be treated with "Medifoam H" or "Duoderm THIN" for a week. During their participation, patients will visit 2 days and a week after to see investigator. Investigator will observe the wound and evaluate amount of exudation, infection status, wound healing.

Conditions

• Trauma

Interventions

Type	Name	Description
DEVICE	Medifoam H dressing	Cover "medifoam H" on the wound for a week.
DEVICE	Duoderm THIN dressing	Cover "Duoderm THIN" on the wound for a week

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-03-08
• Last updated: 2013-02-06

Locations

1 site across 1 country: South Korea