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

Seoul St. Mary's Hospital

Status and phase: Completed; Phase 4

Conditions: Trauma

Treatments: Device: Duoderm THIN dressing; Device: Medifoam H dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01548443

BP-MH-D01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Volunteers: No Healthy Volunteers

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:

2. Laceration, Stitched Wound: Length of under 10cm.

3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Medifoam H

Experimental group

Description:

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

Treatment:

Device: Medifoam H dressing

Duoderm THIN

Active Comparator group

Description:

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

Treatment:

Device: Duoderm THIN dressing