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

Joseph M. Still Research Foundation

Status and phase: Completed; Phase 3

Conditions: Wound Drainage; Pain Management; Donor Sites; Wound Heal

Treatments: Device: Xeroform; Device: Mepilex Ag; Device: NovaDress

Study type: Interventional

Funder types: Other

Identifiers

NCT05499104

JMSRF-NCMIS-P01

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

93 participants in 3 patient groups

Mepilex Ag

Active Comparator group

Description:

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

Treatment:

Device: Mepilex Ag

Xeroform

Active Comparator group

Description:

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

Treatment:

Device: Xeroform

NovaDress

Experimental group

Description:

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

Treatment:

Device: NovaDress