Back to resultsA Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Primary Purpose
Donor Sites, Wound Heal, Wound Drainage
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NovaDress
Mepilex Ag
Xeroform
Sponsored by
About this trial
This is an interventional treatment trial for Donor Sites
Eligibility Criteria
Inclusion Criteria:
- Is ≥18 years of age.
- Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.
- Subject is able to provide informed consent.
- Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.
Exclusion Criteria:
- Has a Baux Score of ≥130.
- Subject is intubated, unable to state pain levels.
- Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
- Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
- Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).
- Is pregnant, plans to become pregnant, or is actively breastfeeding.
- Active illicit drug use.
- Is moribund, or in the opinion of the investigator is not expected to survive.
Sites / Locations
- Joseph M. Still Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Mepilex Ag
Xeroform
NovaDress
Arm Description
patient will receive Mepilex Ag for their site, standard of care to be followed.
patient will receive Xeroform for their site, standard of care to be followed.
patient will receive NovaDress for their site, standard of care to be followed.
Outcomes
Primary Outcome Measures
Pain and Healing
To compare and healing (defined as >95% epithelization) at the study donor sites treated with a cellulose dressing to two standard of care dressings- an antimicrobial foam dressing and a bacteriostatic petrolatum based gauze dressing.
Secondary Outcome Measures
Absorbent ability
Ability of dressing to absorb exudate measured by staff satisfaction survey
Conformability
Ability of dressing to maintain shape measured by staff satisfaction survey
Adherence
Ability of dressing to remain fixed in place measured by staff satisfaction survey
Management of bloody exudate
Ability of dressing to absorb bloody exudate measured by staff satisfaction survey
Ease of removal
Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey
Cost
Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey
Full Information
NCT ID
NCT05499104
First Posted
July 20, 2021
Last Updated
August 10, 2022
Sponsor
Joseph M. Still Research Foundation, Inc.
Collaborators
Innovatech Engineering, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05499104
Brief Title
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Official Title
A Prospective, Randomized, Controlled Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joseph M. Still Research Foundation, Inc.
Collaborators
Innovatech Engineering, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Donor Sites, Wound Heal, Wound Drainage, Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mepilex Ag
Arm Type
Active Comparator
Arm Description
patient will receive Mepilex Ag for their site, standard of care to be followed.
Arm Title
Xeroform
Arm Type
Active Comparator
Arm Description
patient will receive Xeroform for their site, standard of care to be followed.
Arm Title
NovaDress
Arm Type
Experimental
Arm Description
patient will receive NovaDress for their site, standard of care to be followed.
Intervention Type
Device
Intervention Name(s)
NovaDress
Intervention Description
NovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated.
Intervention Type
Device
Intervention Name(s)
Mepilex Ag
Intervention Description
Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.
Intervention Type
Device
Intervention Name(s)
Xeroform
Intervention Description
Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
Primary Outcome Measure Information:
Title
Pain and Healing
Description
To compare and healing (defined as >95% epithelization) at the study donor sites treated with a cellulose dressing to two standard of care dressings- an antimicrobial foam dressing and a bacteriostatic petrolatum based gauze dressing.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Absorbent ability
Description
Ability of dressing to absorb exudate measured by staff satisfaction survey
Time Frame
14 days
Title
Conformability
Description
Ability of dressing to maintain shape measured by staff satisfaction survey
Time Frame
14 days
Title
Adherence
Description
Ability of dressing to remain fixed in place measured by staff satisfaction survey
Time Frame
14 days
Title
Management of bloody exudate
Description
Ability of dressing to absorb bloody exudate measured by staff satisfaction survey
Time Frame
14 days
Title
Ease of removal
Description
Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey
Time Frame
14 days
Title
Cost
Description
Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is ≥18 years of age.
Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.
Subject is able to provide informed consent.
Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.
Exclusion Criteria:
Has a Baux Score of ≥130.
Subject is intubated, unable to state pain levels.
Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).
Is pregnant, plans to become pregnant, or is actively breastfeeding.
Active illicit drug use.
Is moribund, or in the opinion of the investigator is not expected to survive.
Facility Information:
Facility Name
Joseph M. Still Research Foundation
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
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