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

Seoul St. Mary's Hospital66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trauma

Interventions

Medifoam H dressingDEVICE

Cover "medifoam H" on the wound for a week.

Duoderm THIN dressingDEVICE

Cover "Duoderm THIN" on the wound for a week

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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: 1. Laceration, Stitched Wound: Length of under 10cm. 2. Abrasion, Burn: Total area of under 100㎠ , Depth of under 2mm. 2. Agreed to participate voluntarily in the study Exclusion Criteria: 1. Who has hypersensitivity to hydrocolloid or its history. 2. Deep or severe infectious diseases of skin(example: Phlegmon, Abscess, Ulcer, Boil etc..) which is hard to treat with this investigational product. 3. A wound which is bitten by animal, human or inject. Or a wound has possibility of secondary infection through the tresis. 4. Who need surgical intervention for infection treatment. 5. Who has bacterial, viral, animal infectious disease 6. Who judged inappropriate to participate in the study by investigator.

Locations (1)

Seoul St. Mary's Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 0 to 1 week

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 3/7 days

Whether use of concomitant medication or not

Time frame: 1/3/7 days

Data from ClinicalTrials.gov

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