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

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

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.

Study Overview

• Status: Completed
• Conditions: Trauma
• Intervention / Treatment: Device: Medifoam H dressing; Device: Duoderm THIN dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul st. mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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
Whether use of concomitant medication or not	Whether use of concomitant medication or not	1/3/7 days

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: The Catholic University of Korea
• Investigators: Principal Investigator: Jong-Won Rhie, MD.,PhD, Seoul st. mary's hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (ESTIMATE): March 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Wound Healing; Wound Dressing; hydrocolloid; Medifoam H; Duoderm THIN; Mild Acute Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: BP-MH-D01