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

NCT ID: NCT05499104

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-16
• Study Completion Date: 2022-02-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mepilex Ag

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

Group Type: ACTIVE_COMPARATOR

Mepilex Ag

Intervention Type: DEVICE

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

Xeroform

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

Group Type: ACTIVE_COMPARATOR

Xeroform

Intervention Type: DEVICE

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

NovaDress

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

Group Type: EXPERIMENTAL

NovaDress

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Mepilex Ag

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

Intervention Type: DEVICE

Xeroform

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovatech Engineering, LLC

UNKNOWN

Sponsor Role: collaborator

Joseph M. Still Research Foundation, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Joseph M. Still Research Foundation

Augusta, Georgia, United States

Countries

United States

Other Identifiers

JMSRF-NCMIS-P01

Identifier Type: -

Identifier Source: org_study_id