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

Primary Purpose

Trauma

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Medifoam H dressing
Duoderm THIN dressing
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Wound Healing, hydrocolloid, Wound Dressing, Medifoam H, Duoderm THIN, Mild Acute Trauma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medifoam H

Duoderm THIN

Arm Description

A group which treated with "medifoam H" on the wound.

A group which treated with " Duoderm THIN " on the wound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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
Whether use of concomitant medication or not
Whether use of concomitant medication or not

Full Information

First Posted
March 5, 2012
Last Updated
February 5, 2013
Sponsor
Seoul St. Mary's Hospital
Collaborators
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01548443
Brief Title
Study to Evaluate Clinical Efficacy and Safety of "Medifoam H" in Wound Healing
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
Wound Healing, hydrocolloid, Wound Dressing, Medifoam H, Duoderm THIN, Mild Acute Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medifoam H
Arm Type
Experimental
Arm Description
A group which treated with "medifoam H" on the wound.
Arm Title
Duoderm THIN
Arm Type
Active Comparator
Arm Description
A group which treated with " Duoderm THIN " on the wound
Intervention Type
Device
Intervention Name(s)
Medifoam H dressing
Intervention Description
Cover "medifoam H" on the wound for a week.
Intervention Type
Device
Intervention Name(s)
Duoderm THIN dressing
Intervention Description
Cover "Duoderm THIN" on the wound for a week
Primary Outcome Measure Information:
Title
Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery
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. Exudation will be scored in 4 level: None/Mild/Normal/Severe.
Time Frame
0 to 1 week
Secondary Outcome Measure Information:
Title
Rate of infection on wound
Description
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.
Time Frame
1/3/7 days.
Title
Amount of exudation at day 3.
Description
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
Time Frame
3 days
Title
Rate of wound healing
Description
Rate of wound healing at day 3 and 7 from baseline. Would healing will be scored in 3 level: Better/Same/Worse.
Time Frame
3/7 days
Title
Rate of changes in tissue after treatment
Description
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
Time Frame
3/7 days
Title
Whether use of concomitant medication or not
Description
Whether use of concomitant medication or not
Time Frame
1/3/7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Won Rhie, MD.,PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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