NCT01365273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 14, 2012

Completed
Last Updated

February 13, 2014

Status Verified

August 1, 2012

Enrollment Period

10 months

First QC Date

May 27, 2011

Results QC Date

May 2, 2012

Last Update Submit

January 17, 2014

Conditions

Deep Partial Thickness BurnFull Thickness Burns

Keywords

Split thickness skin graftsMepitel OneBridal Veil and staplesPain

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Device: Mepitel One

Interventions

Mepitel OneDEVICE

Dressing

Mepitel One

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Foundation for Education & Research, Inc

Tampa, Florida, 33606, United States

Location

Joseph M. Still Research Foundation, Inc.

Augusta, Georgia, 30909, United States

Location

5028 Delp Bldg, Mail stop 1011

Kansas City, Kansas, 66160, United States

Location

Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center

Upland, Pennsylvania, 19013, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Joan Wilson, MSN, MHA, RN
Organization
Monlycke Health Care
joan.wilson@molnlycke.com
706 504 8997

Study Officials

  • Mary Lou Patton, MD

    Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 3, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 13, 2014

Results First Posted

September 14, 2012

Record last verified: 2012-08

Locations

US(4)