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

Trauma Clinical Trial

— Medifoam H  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548443
• Other study ID #: BP-MH-D01
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2012
• Last updated: February 5, 2013
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma

Intervention

Device:
• Medifoam H dressing
Cover "medifoam H" on the wound for a week.
• Duoderm THIN dressing
Cover "Duoderm THIN" on the wound for a week

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery	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.	0 to 1 week	No
Secondary	Rate of infection on wound	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.	1/3/7 days.	No
Secondary	Amount of exudation at day 3.	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 days	No
Secondary	Rate of wound healing	Rate of wound healing at day 3 and 7 from baseline. Would healing will be scored in 3 level: Better/Same/Worse.	3/7 days	No
Secondary	Rate of changes in tissue after treatment	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	3/7 days	No
Secondary	Whether use of concomitant medication or not	Whether use of concomitant medication or not	1/3/7 days	No