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.

Study Overview

• Status: Completed
• Conditions: Deep Partial Thickness Burn; Full Thickness Burns
• Intervention / Treatment: Device: Mepitel One

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University Foundation for Education & Research, Inc
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Research Foundation, Inc.
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • 5028 Delp Bldg, Mail stop 1011
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19013
      • Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Mary Lou Patton, MD, Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Split thickness skin grafts; Mepitel One; Bridal Veil and staples
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MPTO 04