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OpenTrials
Completed

NCT Number: NCT01548443

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul St. Mary's Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Medifoam H dressing

Device

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

Duoderm THIN dressing

Device

Cover "Duoderm THIN" on the wound for a week

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

    Time frame: 0 to 1 week

    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.

Secondary outcomes

  1. Rate of infection on wound

    Time frame: 1/3/7 days.

    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.

  2. Amount of exudation at day 3.

    Time frame: 3 days

    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. Rate of wound healing

    Time frame: 3/7 days

    Rate of wound healing at day 3 and 7 from baseline. Would healing will be scored in 3 level: Better/Same/Worse.

  4. Rate of changes in tissue after treatment

    Time frame: 3/7 days

    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

  5. Whether use of concomitant medication or not

    Time frame: 1/3/7 days

    Whether use of concomitant medication or not

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • The Catholic University of Korea

Registry information

Official study 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

Acronym: Medifoam H

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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