Study to Evaluate Clinical Efficacy and Safety of "Medifoam H" in Wound Healing
- Conditions
- Trauma
- Interventions
- Device: Medifoam H dressingDevice: Duoderm THIN dressing
- Registration Number
- NCT01548443
- Lead Sponsor
- Seoul St. Mary's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medifoam H Medifoam H dressing A group which treated with "medifoam H" on the wound. Duoderm THIN Duoderm THIN dressing A group which treated with " Duoderm THIN " on the wound
- Primary Outcome Measures
Name Time Method Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery 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 Outcome Measures
Name Time Method Rate of infection on wound 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. 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 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 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 1/3/7 days Whether use of concomitant medication or not
Trial Locations
- Locations (1)
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of