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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepitel One | Device | Dressing |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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". | 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". | Visit 6, day 7 |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Lou Patton, MD | Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Foundation for Education & Research, Inc | Tampa | Florida | 33606 | United States | ||
| Joseph M. Still Research Foundation, Inc. |
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Date of first patient included: 26 April 2011 Date of last patient completed: 01 December 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Bridal Veil and Staples | Bridal Veil and staples are standard of care I |
| FG001 | Mepitel One | Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Augusta |
| Georgia |
| 30909 |
| United States |
| 5028 Delp Bldg, Mail stop 1011 | Kansas City | Kansas | 66160 | United States |
| Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center | Upland | Pennsylvania | 19013 | United States |
| Compl. Pts, Not Evaluable for Pain. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bridal Veil and Staples | Bridal Veil and staples are standard of care I |
| BG001 | Mepitel One | Device |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis. | Posted | Median | Standard Deviation | units on a scale | At visit 6, day 7 |
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| Primary | 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". | All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses. | Posted | Median | Standard Deviation | units on a scale | Visit 6, day 7 |
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| Primary | 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". | All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis. | Posted | Median | Standard Deviation | units on a scale | Visit 6, day 7 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bridal Veil and Staples | Bridal Veil and staples are standard of care I | 0 | 22 | 0 | 22 | ||
| EG001 | Mepitel One | Device | 0 | 21 | 0 | 21 |
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Sponsor is the owner of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Wilson, MSN, MHA, RN | Monlycke Health Care | 706 504 8997 | joan.wilson@molnlycke.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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