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Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns

Primary Purpose

Burns, Skin Burn Requiring Skin Graft

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P6 Low Adherent Dressing
Standard of Care (SOC)
Sponsored by
Milliken Healthcare Products, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burns

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have thermal burns from scalds, flame/fire or contact with a hot object.
  • Patients must have a TBSA burn of less than or equal to 50%.
  • Patients must have two nonadjacent study burn sites (i.e., separated in such a way that SOC dressing does not contaminate the study dressing) of comparable size (up to approximately 2% TBSA) and severity requiring excision and grafting.
  • Patients must have undergone excision and autografting on or before post-burn day (PBD) 14.
  • Patients' study burn sites will be treated with skin grafts with a mesh ratio up to 3:1, at the surgeon's discretion.
  • Patients expected to be available for assessment of study burn sites at least until POD 6 ±1 day.
  • Males or females at least 18 years of age but no older than 65 years of age at the time of informed consent.
  • Patient and / or Legally Authorized Representative (LAR) voluntarily agrees to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.

Exclusion Criteria:

  • Patients with electrical or chemical burns.
  • Patients with a study burn site excised and "grafted" with Integra.
  • Patients with study burn sites on the buttocks, scalp, hands, feet, neck or ears.
  • Patients taking vasopressors or inotropes.
  • Patients using systemic immunosuppressants (e.g., corticosteroids and anti-neoplastic agents, etc.).
  • Patients with acute renal failure, defined as creatinine clearance (CrCL) >2.5 mg/dL or AKIN score greater than or equal to 2 or estimated GFR < 30, if the assessment is conducted as part of the patient's routine clinical care.
  • Patients with acute respiratory distress syndrome (ARDS), if the assessment is conducted as part of the patient's routine clinical care.
  • Patients with liver cirrhosis (Childs-Pugh B Class or greater) or who have AST / ALT levels greater than or equal to 2 times the upper limit of theinstitution's normal range, if the assessment is conducted as part of the patient's routine clinical care.
  • Patients with a known sensitivity or known intolerance to mafenide acetate (Sulfamylon) or to silver.
  • Patients with any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study.
  • Patients who are breastfeeding, pregnant or expecting to become pregnant during the study..
  • Patients who have been exposed to an investigational drug or device within 30 days prior to Screening or is scheduled to receive another investigational drug or device during either the Treatment Phase or Follow-up Evaluation.

Sites / Locations

  • Shands at University of Florida
  • University of North Carolina, Chapel Hill
  • Wake Forest University Health Sciences
  • University of Tennessee Firefighter's Regional Burn Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

P6 Low Adherent Dressing

Standard of Care (SOC)

Arm Description

All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).

All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).

Outcomes

Primary Outcome Measures

Management of skin grafts as determined by investigator's visual assessment of percent graft take

Secondary Outcome Measures

The incidence of post-operative graft infections
Assessment of patient's pain / discomfort, using a visual analog scale.
Costs of study burn site wound dressing regimens.
Ease of use and clinician preference of the study burn site wound dressing regimens
Statistical robustness of visual graft take assessments in-person and from digital photographs
Progression of percent graft take with time for both P6 and SOC.
Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.

Full Information

First Posted
July 24, 2012
Last Updated
September 29, 2017
Sponsor
Milliken Healthcare Products, LLC
Collaborators
Criterium, Inc., U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01654094
Brief Title
Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns
Official Title
A Multicenter, Prospective, Randomized Study to Compare Milliken Dressing P6 to Mafenide Acetate 5% Solution as a Split Thickness Skin Graft Cover Dressing in Burn Wound Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milliken Healthcare Products, LLC
Collaborators
Criterium, Inc., U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Skin Burn Requiring Skin Graft

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P6 Low Adherent Dressing
Arm Type
Experimental
Arm Description
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
Intervention Type
Device
Intervention Name(s)
P6 Low Adherent Dressing
Intervention Description
Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
Intervention Type
Other
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
Primary Outcome Measure Information:
Title
Management of skin grafts as determined by investigator's visual assessment of percent graft take
Time Frame
6 days
Secondary Outcome Measure Information:
Title
The incidence of post-operative graft infections
Time Frame
15 days
Title
Assessment of patient's pain / discomfort, using a visual analog scale.
Time Frame
15 days
Title
Costs of study burn site wound dressing regimens.
Time Frame
15 days
Title
Ease of use and clinician preference of the study burn site wound dressing regimens
Time Frame
15 days
Title
Statistical robustness of visual graft take assessments in-person and from digital photographs
Time Frame
15 days
Title
Progression of percent graft take with time for both P6 and SOC.
Time Frame
15 days
Title
Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have thermal burns from scalds, flame/fire or contact with a hot object. Patients must have a TBSA burn of less than or equal to 50%. Patients must have two nonadjacent study burn sites (i.e., separated in such a way that SOC dressing does not contaminate the study dressing) of comparable size (up to approximately 2% TBSA) and severity requiring excision and grafting. Patients must have undergone excision and autografting on or before post-burn day (PBD) 14. Patients' study burn sites will be treated with skin grafts with a mesh ratio up to 3:1, at the surgeon's discretion. Patients expected to be available for assessment of study burn sites at least until POD 6 ±1 day. Males or females at least 18 years of age but no older than 65 years of age at the time of informed consent. Patient and / or Legally Authorized Representative (LAR) voluntarily agrees to provide written informed consent and the willingness and ability to comply with all aspects of the protocol. Exclusion Criteria: Patients with electrical or chemical burns. Patients with a study burn site excised and "grafted" with Integra. Patients with study burn sites on the buttocks, scalp, hands, feet, neck or ears. Patients taking vasopressors or inotropes. Patients using systemic immunosuppressants (e.g., corticosteroids and anti-neoplastic agents, etc.). Patients with acute renal failure, defined as creatinine clearance (CrCL) >2.5 mg/dL or AKIN score greater than or equal to 2 or estimated GFR < 30, if the assessment is conducted as part of the patient's routine clinical care. Patients with acute respiratory distress syndrome (ARDS), if the assessment is conducted as part of the patient's routine clinical care. Patients with liver cirrhosis (Childs-Pugh B Class or greater) or who have AST / ALT levels greater than or equal to 2 times the upper limit of theinstitution's normal range, if the assessment is conducted as part of the patient's routine clinical care. Patients with a known sensitivity or known intolerance to mafenide acetate (Sulfamylon) or to silver. Patients with any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study. Patients who are breastfeeding, pregnant or expecting to become pregnant during the study.. Patients who have been exposed to an investigational drug or device within 30 days prior to Screening or is scheduled to receive another investigational drug or device during either the Treatment Phase or Follow-up Evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Cairns, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Tennessee Firefighter's Regional Burn Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States

12. IPD Sharing Statement

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Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns

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