TraumaPhase 4Medifoam HNCT01548443
Study to Evaluate Clinical Efficacy and Safety of "Medifoam H" in Wound Healing
A Phase 4 study testing Medifoam H dressing and Duoderm THIN dressing in people with Trauma, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- What is being tested?
- Medifoam H dressing and Duoderm THIN dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Medifoam H dressing, Duoderm THIN dressing
- Keywords
- Wound Healing, hydrocolloid, Wound Dressing, Medifoam H, Duoderm THIN, Mild Acute Trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medifoam H dressingDevice
Cover "medifoam H" on the wound for a week.
Duoderm THIN dressingDevice
Cover "Duoderm THIN" on the wound for a week
| Study group | Role | What they receive |
|---|---|---|
| Medifoam H | Experimental | A group which treated with "medifoam H" on the wound. Receives: Device: Medifoam H dressing |
| Duoderm THIN | Active comparator | A group which treated with " Duoderm THIN " on the wound Receives: Device: Duoderm THIN dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 1 week
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 3/7 days
Whether use of concomitant medication or not
Whether use of concomitant medication or not
Measured: 1/3/7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea
- Responsible party
- Principal investigator, Jong-Won Rhie, Seoul St. Mary's Hospital
- Investigators
- Jong-Won Rhie, MD.,PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548443
- Sponsor's protocol ID
- BP-MH-D01
- Acronym
- Medifoam H
- Status last verified
- Feb 2013
- First submitted
- 5 Mar 2012
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01548443
- Acronym / sponsor ID
- Medifoam H / BP-MH-D01
- Conditions
- Trauma
- Keywords
- Wound Healing, hydrocolloid, Wound Dressing, Medifoam H, Duoderm THIN, Mild Acute Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medifoam H | Experimental | Device: Medifoam H dressingA group which treated with "medifoam H" on the wound. |
| Duoderm THIN | Active comparator | Device: Duoderm THIN dressingA group which treated with " Duoderm THIN " on the wound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medifoam H dressingCover "medifoam H" on the wound for a week. | Device | Medifoam H |
| Duoderm THIN dressingCover "Duoderm THIN" on the wound for a week | Device | Duoderm THIN |
Primary outcome
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
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.
5 secondary outcomes
Rate of infection on wound
Time frame: 1/3/7 days.
Amount of exudation at day 3.
Time frame: 3 days
Rate of wound healing
Time frame: 3/7 days
Rate of changes in tissue after treatment
Time frame: 3/7 days
Whether use of concomitant medication or not
Time frame: 1/3/7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Won Rhie, MD.,PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medifoam H dressing and Duoderm THIN dressing in people with Trauma, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.