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

This study has been completed.
Sponsor:
Collaborator:
The Catholic University of Korea
Information provided by (Responsible Party):
Jong-Won Rhie, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01548443
First received: March 5, 2012
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Trauma
Device: Medifoam H dressing
Device: Duoderm THIN dressing
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

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 [ Time Frame: 0 to 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1/3/7 days. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3/7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3/7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1/3/7 days ] [ Designated as safety issue: No ]
    Whether use of concomitant medication or not


Enrollment: 66
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548443

Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul St. Mary's Hospital
The Catholic University of Korea
Investigators
Principal Investigator: Jong-Won Rhie, MD.,PhD Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Jong-Won Rhie, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01548443     History of Changes
Other Study ID Numbers: BP-MH-D01
Study First Received: March 5, 2012
Last Updated: February 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul St. Mary's Hospital:
Wound Healing
hydrocolloid
Wound Dressing
Medifoam H
Duoderm THIN
Mild Acute Trauma

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014