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Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01365273
First received: May 27, 2011
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Deep Partial Thickness Burn
Full Thickness Burns
 Device: Mepitel One
 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: Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • VAS Score for Pain Before Dressing Removal [ Time Frame: At visit 6, day 7 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".


Enrollment: 43
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Bridal Veil together with staples
Standard of care. Bridal Veil is fixed over the graft with staples.
Active Comparator: Mepitel One
Device, dressing
 Device: Mepitel One
Dressing

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria

    1. Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft
    2. 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)
    3. Both genders with age ≥18 years but < 70 years
    4. Signed informed consent

Exclusion Criteria:

  1. Subjects with chronic wounds
  2. Subjects who are on mechanical ventilation
  3. Subjects with dermatologic skin conditions or necrotizing disorders
  4. Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment
  5. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent
  6. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
  7. Known allergy/hypersensitivity to any of the components of the investigational products
  8. Subjects with physical and/or mental conditions that are not expected to comply with the investigation
  9. Participation in other clinical investigation(s) within 1 month prior to start of the investigation
  10. Previously randomised to this investigation
  11. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365273

Locations
United States, Florida
University Foundation for Education & Research, Inc
Tampa, Florida, United States, 33606
United States, Georgia
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, United States, 30909
United States, Kansas
5028 Delp Bldg, Mail stop 1011
Kansas City, Kansas, United States, 66160
United States, Pennsylvania
Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center
Upland, Pennsylvania, United States, 19013
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Mary Lou Patton, MD Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01365273     History of Changes
Other Study ID Numbers: MPTO 04
Study First Received: May 27, 2011
Results First Received: May 2, 2012
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Molnlycke Health Care AB:
Split thickness skin grafts
Mepitel One
Bridal Veil and staples
Pain

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013