Donor Site ComplicationNCT01670201
An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
A study testing Mepilex Transfer Ag in people with Donor Site Complication, run by Molnlycke Health Care AB at 2 sites in United States.
Trial summary
The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Donor Site Complication
- What is being tested?
- Mepilex Transfer Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgical donor sites for deep partial-thickness or full-thickness burns
- Burn of thermal origin
- Both genders with an age ≥ 7 years at enrolment
- Signed informed consent
- Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.
Who cannot join
- Any known or suspected systemic infection
- Any known sensitivity to silver or other components/products used in this study.
- Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry.
- Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation.
- Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
- Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed).
Show all 9Show fewer
- Subject unwilling to comply with 28 day follow-up.
- Participation in another investigational study while participating in this study.
- Bleeding disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
LongIsland Plastic Surgical Group, PC
Garden City, New York, 11530
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.
The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.
Treatment will be initiated in the operation room following debridement and split thickness grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be applied directly to study site. Secondary dressing will include covering with ace wrap.
Healing should be asses after 10-14 days.
Read the detailed description
A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site".
- Conditions
- Donor Site Complication
- Being tested
- Mepilex Transfer Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Transfer AgDevice
Silver dressing
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Transfer Ag | Experimental | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Receives: Device: Mepilex Transfer Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had > 95 % Epithelialization at Day 10
Measured: 10 days
Secondary outcomes (1)
Pain at Dressing Changes
The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.
Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),
Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Donor Site ComplicationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Gibran, MD, Principal investigator, UW Medicine Regional Burn Center Seattle, WA 98104
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670201
- Sponsor's protocol ID
- MxT Ag 01
- Status last verified
- Feb 2013
- First submitted
- 12 Jun 2012
- Last updated
- 10 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.
- ClinicalTrials.gov ID
- NCT01670201
- Acronym / sponsor ID
- MxT Ag 01
- Conditions
- Donor Site Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Posted 10 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.
Treatment will be initiated in the operation room following debridement and split thickness grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be applied directly to study site. Secondary dressing will include covering with ace wrap.
Healing should be asses after 10-14 days.
Detailed description
A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mepilex Transfer Ag | Experimental | Device: Mepilex Transfer AgMepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Surgical donor sites for deep partial-thickness or full-thickness burns
- Burn of thermal origin
- Both genders with an age ≥ 7 years at enrolment
- Signed informed consent
- Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.
Key exclusion criteria (9 listed)
- Any known or suspected systemic infection
- Any known sensitivity to silver or other components/products used in this study.
- Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry.
- Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation.
- Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
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 |
|---|---|---|
| Mepilex Transfer AgSilver dressing | Device | Mepilex Transfer Ag |
Primary outcome
Percentage of Participants Who Had > 95 % Epithelialization at Day 10
Time frame: 10 days
1 secondary outcome
Pain at Dressing Changes
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicole Gibran, MD principal investigator
UW Medicine Regional Burn Center Seattle, WA 98104
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Transfer Ag in people with Donor Site Complication, run by Molnlycke Health Care AB at 2 sites in United States.
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 5 inclusion and 9 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 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Had > 95 % Epithelialization at Day 10 (time frame: 10 days). 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 10 Sep 2014.