Deep Partial Thickness BurnPhase 4NCT01365273
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
A Phase 4 study testing Mepitel One in people with Deep Partial Thickness Burn and Full Thickness Burns, run by Molnlycke Health Care AB at 4 sites in United States.
Trial summary
This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Deep Partial Thickness Burn, Full Thickness Burns
- What is being tested?
- Mepitel One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2011to Dec 2011
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft
- At least 1%-10% TBSA is available for grafting that can be considered for study site selection (must have intact, healthy peri-wound area around entire portion of this burned site)
- Both genders with age ≥18 years but < 70 years
- Signed informed consent
Who cannot join
- Subjects with chronic wounds
- Subjects who are on mechanical ventilation
- Subjects with dermatologic skin conditions or necrotizing disorders
- Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment
- Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent
- Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
Show all 11Show fewer
- Known allergy/hypersensitivity to any of the components of the investigational products
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- Previously randomised to this investigation
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, 30909
5028 Delp Bldg, Mail stop 1011
Kansas City, Kansas, 66160
University Foundation for Education & Research, Inc
Tampa, Florida, 33606
Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center
Upland, Pennsylvania, 19013
About this study
Official title: Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples.
The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.
Read the detailed description
Skin grafts are placed over excised areas of full thickness injuries and usually attached with sutures or staples. While useful in anchoring the graft in place, subjects often complain of pain from the staples as wound healing progresses.Pulling and sticking are common complaints.There is also a possibility that staples become embedded in the graft which leads to disruption of otherwise healed area, increased pain and anxiety for the subject as well as anxiety for the staff.
Graft take can be optimized with appropriate medical management. Use of non-adherent dressings to protect the graft is customary. Various types of netting-style are used, such as Bridal veil, a sterile product which is fixed over the graft with staples.
Silicone net dressings have also been used successfully to prevent lifting and adherence of skin grafts to the dressings, prevent pain and promote healing. Mepitel One is a sterile, transparent, and flexible wound contact layer consisting of perforated polyurethane film coated with Safetac soft silicone adhesive on one side. Mepitel One is available in various sizes and can be left in place for several days depending on the wound/skin condition.
Evaluation of burns will be performed at Baseline. Skin graft assessment will be performed at Day 7 and Day 14. End of study will be considered the time that graft is considered to have >95% take.
- Conditions
- Deep Partial Thickness Burn, Full Thickness Burns
- Being tested
- Mepitel One
- Keywords
- Split thickness skin grafts, Mepitel One, Bridal Veil and staples, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel OneDevice
Dressing
| Study group | Role | What they receive |
|---|---|---|
| Bridal Veil together with staples | No intervention | Standard of care. Bridal Veil is fixed over the graft with staples. |
| Mepitel One | Active comparator | Device, dressing Receives: Device: Mepitel One |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Score for Pain Before Dressing Removal
Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.
Measured: At visit 6, day 7
VAS Score for Pain During Dressing Removal
Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
Measured: Visit 6, day 7
VAS Score for Pain After Dressing Removal
Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
Measured: Visit 6, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Deep Partial Thickness BurnStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Lou Patton, MD, Principal investigator, Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365273
- Sponsor's protocol ID
- MPTO 04
- Status last verified
- Aug 2012
- First submitted
- 27 May 2011
- Last updated
- 13 Feb 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 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
- ClinicalTrials.gov ID
- NCT01365273
- Acronym / sponsor ID
- MPTO 04
- Conditions
- Deep Partial Thickness Burn, Full Thickness Burns
- Keywords
- Split thickness skin grafts, Mepitel One, Bridal Veil and staples, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 14 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples.
The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.
Detailed description
Skin grafts are placed over excised areas of full thickness injuries and usually attached with sutures or staples. While useful in anchoring the graft in place, subjects often complain of pain from the staples as wound healing progresses.Pulling and sticking are common complaints.There is also a possibility that staples become embedded in the graft which leads to disruption of otherwise healed area, increased pain and anxiety for the subject as well as anxiety for the staff.
Graft take can be optimized with appropriate medical management. Use of non-adherent dressings to protect the graft is customary. Various types of netting-style are used, such as Bridal veil, a sterile product which is fixed over the graft with staples.
Silicone net dressings have also been used successfully to prevent lifting and adherence of skin grafts to the dressings, prevent pain and promote healing. Mepitel One is a sterile, transparent, and flexible wound contact layer consisting of perforated polyurethane film coated with Safetac soft silicone adhesive on one side. Mepitel One is available in various sizes and can be left in place for several days depending on the wound/skin condition.
Evaluation of burns will be performed at Baseline. Skin graft assessment will be performed at Day 7 and Day 14. End of study will be considered the time that graft is considered to have >95% take.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridal Veil together with staples | No intervention | –Standard of care. Bridal Veil is fixed over the graft with staples. |
| Mepitel One | Active comparator | Device: Mepitel OneDevice, dressing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (11 listed)
- Subjects with chronic wounds
- Subjects who are on mechanical ventilation
- Subjects with dermatologic skin conditions or necrotizing disorders
- Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment
- Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent
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 |
|---|---|---|
| Mepitel OneDressing | Device | Mepitel One |
Primary outcome
VAS Score for Pain Before Dressing Removal
Time frame: At visit 6, day 7
Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.
VAS Score for Pain During Dressing Removal
Time frame: Visit 6, day 7
Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
VAS Score for Pain After Dressing Removal
Time frame: Visit 6, day 7
Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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.
Mary Lou Patton, MD principal investigator
Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepitel One in people with Deep Partial Thickness Burn and Full Thickness Burns, run by Molnlycke Health Care AB at 4 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 4 inclusion and 11 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Yes. Results are posted in the registry (first posted 14 Sep 2012). 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?
VAS Score for Pain Before Dressing Removal (time frame: At visit 6, day 7). The study lists 3 primary outcomes in all. 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 13 Feb 2014.