A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickn… (NCT05499104) | Clinical Trial Compass
CompletedPhase 3
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
United States93 participantsStarted 2021-07-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.