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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Device: Medifoam H dressing
* Device: Duoderm THIN dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Who has acute trauma(Laceration, Abrasion, Stitched wound, under superficial second-degree burn etc.)who satisfies at least 1 condition between followings: Laceration, Stitched Wound: Length of under 10cm. Abrasion, Burn: Total area of under 100㎠ , Depth of under 2mm. 2. Agreed to participate voluntarily in the study Exclusion Criteria: Who has hypersensitivity to hydrocolloid or its history. Deep or severe infectious diseases of skin(example: Phlegmon, Abscess, Ulcer, Boil etc..) which is hard to treat with this investigational product. A wound which is bitten by animal, human or inject. Or a wound has possibility of secondary infection through the tresis. Who need surgical intervention for infection treatment. Who has bacterial, viral, animal infectious disease Who judged inappropriate to participate in the study by investigator.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medifoam H<br>A group which treated with medifoam H on the wound. | Device: Medifoam H dressing<br>* Cover medifoam H on the wound for a week.<br>|
| Active Comparator: Duoderm THIN<br>A group which treated with  Duoderm THIN  on the wound | Device: Duoderm THIN dressing<br>* Cover Duoderm THIN on the wound for a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery | Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery. Exudation will be scored in 4 level: None/Mild/Normal/Severe. | 0 to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infection on wound | Rate of infection on wound. Infection means pus, erythema or tenderness and this will be judged by observation of investigator and scored in 3 level: not present/minimally present/extensively present. | 1/3/7 days. | 
| Amount of exudation at day 3. | Amount of exudation at day 3 from baseline. If exudation is not existed, this will be defined as recovery. Exudation will be scored in 4 level: None/Mild/Normal/Severe | 3 days | 
| Rate of wound healing | Rate of wound healing at day 3 and 7 from baseline. Would healing will be scored in 3 level: Better/Same/Worse. | 3/7 days | 
| Rate of changes in tissue after treatment | Rate of changes in tissue after treatment at day 3 and 7 from baseline. Changes in tissue will be recorded as percentage. Necrotic, sloughy, fibrous, granulation, epithelial, other tissues will be observed | 3/7 days | 
| Whether use of concomitant medication or not | Whether use of concomitant medication or not | 1/3/7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound Healing, hydrocolloid, Wound Dressing, Medifoam H, Duoderm THIN, Mild Acute Trauma