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

Phase 3

Completed

• Conditions: Wound Heal; Wound Drainage; Pain Management; Donor Sites
• Interventions: Device: Xeroform; Device: NovaDress; Device: Mepilex Ag

• Registration Number: NCT05499104
• Lead Sponsor: Joseph M. Still Research Foundation, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-16
• Study First Submitted: 2021-07-20
• Primary Completion: 2022-01-24
• Study Completion: 2022-02-04
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xeroform	Xeroform	patient will receive Xeroform for their site, standard of care to be followed.
NovaDress	NovaDress	patient will receive NovaDress for their site, standard of care to be followed.
Mepilex Ag	Mepilex Ag	patient will receive Mepilex Ag for their site, standard of care to be followed.

Primary Outcome Measures

Name	Time	Method
Pain and Healing	14 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Joseph M. Still Research Foundation; 🇺🇸 Augusta, Georgia, United States