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Completed

NCT Number: NCT05499104

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NovaDress

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.

Mepilex Ag

Device

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

Xeroform

Device

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

Primary outcomes

  1. Pain and Healing

    Time frame: 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 outcomes

  1. Absorbent ability

    Time frame: 14 days

    Ability of dressing to absorb exudate measured by staff satisfaction survey

  2. Conformability

    Time frame: 14 days

    Ability of dressing to maintain shape measured by staff satisfaction survey

  3. Adherence

    Time frame: 14 days

    Ability of dressing to remain fixed in place measured by staff satisfaction survey

  4. Management of bloody exudate

    Time frame: 14 days

    Ability of dressing to absorb bloody exudate measured by staff satisfaction survey

  5. Ease of removal

    Time frame: 14 days

    Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey

  6. Cost

    Time frame: 14 days

    Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey

Sponsors and collaborators

Lead sponsor

Joseph M. Still Research Foundation, Inc.

Other

Collaborators

  • Innovatech Engineering, LLC

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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