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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medifoam H

A group which treated with "medifoam H" on the wound.

Group Type EXPERIMENTAL

Medifoam H dressing

Intervention Type DEVICE

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

Duoderm THIN

A group which treated with " Duoderm THIN " on the wound

Group Type ACTIVE_COMPARATOR

Duoderm THIN dressing

Intervention Type DEVICE

Cover "Duoderm THIN" on the wound for a week

Interventions

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Medifoam H dressing

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

Intervention Type DEVICE

Duoderm THIN dressing

Cover "Duoderm THIN" on the wound for a week

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No