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

NCT01548443 | Completed Phase 4

• 1 other identifier: BP-MH-D01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

Wound Healing; hydrocolloid; Wound Dressing; Medifoam H; Duoderm THIN; Mild Acute Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of infection on wound

  1/3/7 days.

• Amount of exudation at day 3.

  3 days

• Rate of wound healing

  3/7 days

• Rate of changes in tissue after treatment

  3/7 days

• Whether use of concomitant medication or not

  1/3/7 days

Study Arms (2)

Medifoam H

EXPERIMENTAL

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

Device: Medifoam H dressing

Duoderm THIN

ACTIVE COMPARATOR

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

Device: Duoderm THIN dressing

Interventions

Medifoam H dressing DEVICE

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

Medifoam H

Duoderm THIN dressing DEVICE

Cover "Duoderm THIN" on the wound for a week

Duoderm THIN

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• The Catholic University of Korea: collaborator

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jong-Won Rhie, MD.,PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

KR (1)