Donor SitesPhase 3NCT05499104
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
A Phase 3 study testing NovaDress, Mepilex Ag and Xeroform in people with Donor Sites and Wound Heal, run by Joseph M. Still Research Foundation, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Donor Sites, Wound Heal, Wound Drainage
- What is being tested?
- NovaDress, Mepilex Ag and Xeroform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 4 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Joseph M. Still Research Foundation
Augusta, Georgia, 30909
About this study
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.
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.
- Conditions
- Donor Sites, Wound Heal, Wound Drainage, Pain Management
- Being tested
- NovaDress, Mepilex Ag, Xeroform
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaDressDevice
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 AgDevice
Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.
XeroformDevice
Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Ag | Active comparator | patient will receive Mepilex Ag for their site, standard of care to be followed. Receives: Device: Mepilex Ag |
| Xeroform | Active comparator | patient will receive Xeroform for their site, standard of care to be followed. Receives: Device: Xeroform |
| NovaDress | Experimental | patient will receive NovaDress for their site, standard of care to be followed. Receives: Device: NovaDress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (6)
Absorbent ability
Ability of dressing to absorb exudate measured by staff satisfaction survey
Measured: 14 days
Conformability
Ability of dressing to maintain shape measured by staff satisfaction survey
Measured: 14 days
Adherence
Ability of dressing to remain fixed in place measured by staff satisfaction survey
Measured: 14 days
Management of bloody exudate
Ability of dressing to absorb bloody exudate measured by staff satisfaction survey
Measured: 14 days
Ease of removal
Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey
Measured: 14 days
Cost
Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start16 Jul 2021
- Primary completion24 Jan 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor SitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph M. Still Research Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Innovatech Engineering, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499104
- Sponsor's protocol ID
- JMSRF-NCMIS-P01
- Status last verified
- Aug 2022
- First submitted
- 20 Jul 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05499104
- Acronym / sponsor ID
- JMSRF-NCMIS-P01
- Conditions
- Donor Sites, Wound Heal, Wound Drainage, Pain Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Joseph M. Still Research Foundation, Inc.University, hospital or other
- Collaborators
- Innovatech Engineering, LLC
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mepilex Ag | Active comparator | Device: Mepilex Agpatient will receive Mepilex Ag for their site, standard of care to be followed. |
| Xeroform | Active comparator | Device: Xeroformpatient will receive Xeroform for their site, standard of care to be followed. |
| NovaDress | Experimental | Device: NovaDresspatient will receive NovaDress for their site, standard of care to be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovaDressNovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated. | Device | NovaDress |
| Mepilex AgMepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. | Device | Mepilex Ag |
| XeroformXeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate. | Device | Xeroform |
Primary outcome
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.
6 secondary outcomes
Absorbent ability
Time frame: 14 days
Conformability
Time frame: 14 days
Adherence
Time frame: 14 days
Management of bloody exudate
Time frame: 14 days
Ease of removal
Time frame: 14 days
Cost
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NovaDress, Mepilex Ag and Xeroform in people with Donor Sites and Wound Heal, run by Joseph M. Still Research Foundation, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Healing (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.