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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05499104
• Other study ID #: JMSRF-NCMIS-P01
• Status: Completed
• Phase: Phase 3
• Start date: July 16, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: August 2022
• Source: Joseph M. Still Research Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 4, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management
• Wound Heal
• Wounds and Injuries

Intervention

Device:
• 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.
• Mepilex Ag
Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.
• Xeroform
Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.

Locations

Country	Name	City	State
United States	Joseph M. Still Research Foundation	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Joseph M. Still Research Foundation, Inc.	Innovatech Engineering, LLC

Country where clinical trial is conducted

United States, 

Outcome

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