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

NCT05499104 | Completed Phase 3 FDA Device

• 1 other identifier: JMSRF-NCMIS-P01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Donor Sites; Wound Heal; Wound Drainage; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Absorbent ability

  14 days

• Conformability

  14 days

• Adherence

  14 days

• Management of bloody exudate

  14 days

• Ease of removal

  14 days

Study Arms (3)

Mepilex Ag

ACTIVE COMPARATOR

patient will receive Mepilex Ag for their site, standard of care to be followed.

Device: Mepilex Ag

Xeroform

ACTIVE COMPARATOR

patient will receive Xeroform for their site, standard of care to be followed.

Device: Xeroform

NovaDress

EXPERIMENTAL

patient will receive NovaDress for their site, standard of care to be followed.

Device: NovaDress

Interventions

NovaDress DEVICE

NovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated.

NovaDress

Mepilex Ag DEVICE

Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.

Mepilex Ag

Xeroform DEVICE

Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.

Xeroform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joseph M. Still Research Foundation, Inc.: lead
• Innovatech Engineering, LLC: collaborator

Study Sites (1)

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 12, 2022
• Study Start: July 16, 2021
• Primary Completion: January 24, 2022
• Study Completion: February 4, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)