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

Primary Purpose

Deep Partial Thickness Burn, Full Thickness Burns

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mepitel One
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Partial Thickness Burn focused on measuring Split thickness skin grafts, Mepitel One, Bridal Veil and staples, Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Foundation for Education & Research, Inc
  • Joseph M. Still Research Foundation, Inc.
  • 5028 Delp Bldg, Mail stop 1011
  • Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Bridal Veil together with staples

Mepitel One

Arm Description

Standard of care. Bridal Veil is fixed over the graft with staples.

Device, dressing

Outcomes

Primary Outcome Measures

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.
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".
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".

Secondary Outcome Measures

Full Information

First Posted
May 27, 2011
Last Updated
January 17, 2014
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT01365273
Brief Title
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
Official Title
Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Partial Thickness Burn, Full Thickness Burns
Keywords
Split thickness skin grafts, Mepitel One, Bridal Veil and staples, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bridal Veil together with staples
Arm Type
No Intervention
Arm Description
Standard of care. Bridal Veil is fixed over the graft with staples.
Arm Title
Mepitel One
Arm Type
Active Comparator
Arm Description
Device, dressing
Intervention Type
Device
Intervention Name(s)
Mepitel One
Intervention Description
Dressing
Primary Outcome Measure Information:
Title
VAS Score for Pain Before Dressing Removal
Description
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.
Time Frame
At visit 6, day 7
Title
VAS Score for Pain During Dressing Removal
Description
Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
Time Frame
Visit 6, day 7
Title
VAS Score for Pain After Dressing Removal
Description
Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
Time Frame
Visit 6, day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Lou Patton, MD
Organizational Affiliation
Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Foundation for Education & Research, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Joseph M. Still Research Foundation, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
5028 Delp Bldg, Mail stop 1011
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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