A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Wound Heal; Donor Sites; Wound Drainage
• Intervention / Treatment: Device: Mepilex Ag; Device: Xeroform; Device: NovaDress

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Research Foundation

Participation Criteria

Eligibility Criteria

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

Description

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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mepilex Ag; patient will receive Mepilex Ag for their site, standard of care to be followed.	Device: Mepilex Ag; Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.
Active Comparator: Xeroform; patient will receive Xeroform for their site, standard of care to be followed.	Device: Xeroform; Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
Experimental: NovaDress; patient will receive NovaDress for their site, standard of care to be followed.	Device: NovaDress; NovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorbent ability	Ability of dressing to absorb exudate measured by staff satisfaction survey	14 days
Conformability	Ability of dressing to maintain shape measured by staff satisfaction survey	14 days
Adherence	Ability of dressing to remain fixed in place measured by staff satisfaction survey	14 days
Management of bloody exudate	Ability of dressing to absorb bloody exudate measured by staff satisfaction survey	14 days
Ease of removal	Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey	14 days
Cost	Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey	14 days

Collaborators and Investigators

• Sponsor: Joseph M. Still Research Foundation, Inc.
• Collaborators: Innovatech Engineering, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): January 24, 2022
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: JMSRF-NCMIS-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes