Study to Evaluate Clinical Efficacy and Safety of "Medifoam H" in Wound Healing (Medifoam H)
|ClinicalTrials.gov Identifier: NCT01548443|
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : February 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Trauma||Device: Medifoam H dressing Device: Duoderm THIN dressing||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Medifoam H
A group which treated with "medifoam H" on the wound.
Device: Medifoam H dressing
Cover "medifoam H" on the wound for a week.
Active Comparator: Duoderm THIN
A group which treated with " Duoderm THIN " on the wound
Device: Duoderm THIN dressing
Cover "Duoderm THIN" on the wound for a 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 [ 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.
- 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.
- 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
- 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.
- 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
- Whether use of concomitant medication or not [ Time Frame: 1/3/7 days ]Whether use of concomitant medication or not
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548443
|Korea, Republic of|
|Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jong-Won Rhie, MD.,PhD||Seoul St. Mary's Hospital|