Trauma
Conditions
Keywords
Wound Healing, hydrocolloid, Wound Dressing, Medifoam H, Duoderm THIN, Mild Acute Trauma
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.
Interventions
DEVICEMedifoam H dressing
Cover medifoam H on the wound for a week.
DEVICEDuoderm THIN dressing
Cover Duoderm THIN on the wound for a week
Sponsors
The Catholic University of Korea
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed