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: January 17, 2014
Last verified: August 2012

May 27, 2011
January 17, 2014
February 2011
December 2011   (final data collection date for primary outcome measure)
  • 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".
VAS score for pain before, during, and after dressing removal [ Time Frame: August - September 2011 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01365273 on ClinicalTrials.gov Archive Site
Not Provided
  • Efficacy of Mepitel One [ Time Frame: August - September 2011 ] [ Designated as safety issue: Yes ]
    To prevent lifting and adherence of skin grafts to the dressings.
  • Safety of Mepitel One Tolerance of Mepitel One [ Time Frame: August - September 2011 ] [ Designated as safety issue: Yes ]
    Infection in study site
Not Provided
Not Provided
 
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Deep Partial Thickness Burn
  • Full Thickness Burns
Device: Mepitel One
Dressing
  • 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
    Intervention: Device: Mepitel One
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365273
MPTO 04
No
Molnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Principal Investigator: Mary Lou Patton, MD Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center
Molnlycke Health Care AB
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP