Clinical trial NCT01548443: Study to Evaluate Clinical Efficacy and Safety of "Medifoam H" in Wound Healing
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trauma
Keywords: Wound Healing
hydrocolloid
Wound Dressing
Medifoam H
Duoderm THIN
Mild Acute Trauma
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2012-03-08
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery
timeFrame: 0 to 1 week
Secondary outcomes:
measure: Rate of infection on wound
timeFrame: 1/3/7 days.
measure: Amount of exudation at day 3.
timeFrame: 3 days
measure: Rate of wound healing
timeFrame: 3/7 days
measure: Rate of changes in tissue after treatment
timeFrame: 3/7 days
measure: Whether use of concomitant medication or not
timeFrame: 1/3/7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Jong-Won Rhie, MD.,PhD
role: PRINCIPAL_INVESTIGATOR
References: