Burn WoundNCT03723590

A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG

A study testing Esterified Hyaluronic Acid Matrix in people with Burn Wound, run by Medline Industries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Burn Wound
What is being tested?: Esterified Hyaluronic Acid Matrix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: No sites listed yet
Study dates: 6 Feb 2019to 22 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has a wound originating from a thermal or electrical burn
Target burn area is less than 20% of TBSA
Target burn wound is greater than 0.5% of TBSA
Patient has undergone escharectomy procedure or will undergo escharectomy on the target burn and resulting wound will likely need a split thickness skin graft, but wound site is not immediately ready for grafting
For patients with diabetes, an A1C hemoglobin level between 11 percent (taken within 90 days)

Who cannot join

Current active diagnosis of substance abuse, per the Investigator
Patient currently taking non-inhaled corticosteroids
Patient needs or is likely to need negative pressure wound therapy of the target wound after application of Hyalomatrix Wound Device
Patient is pregnant, planning to become pregnant during study period, or breastfeeding
Unstable medical condition as determined by the site investigator
Patients with known sensitivities to hyaluronan, hyaluronan derivatives, silicone, or any other ingredients of the Hyalomatrix Wound Device

About this study

Official title: A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix on Preparing Wounds in Burn Patients for Split-thickness Skin Grafting

Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds. The study will be divided into two phases. Phase I will entail intervention with the wound matrix and will continue until one of the following occur, sufficient granulation has occurred and the patient can receive a STSG and proceed to Phase II, the patient's physician determines an STSG is no longer necessary or two applications with the wound matrix occur and no STSG is approved. Phase II will begin following the STSG procedure. In this phase, the wound will be monitored and proportion of STSG take will be evaluated but no application of the wound matrix device will take place. This phase will continue for 28 days or if the physician deems the patient no longer needs regular care to monitor the wound, whichever occurs earlier.

Conditions: Burn Wound
Being tested: Esterified Hyaluronic Acid Matrix
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esterified Hyaluronic Acid MatrixDevice
A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss

Study groups in NCT03723590
Study group	Role	What they receive
Esterified hyaluronic acid matrix	Experimental	Not described Receives: Device: Esterified Hyaluronic Acid Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
Measured: Baseline to 42 days

Secondary outcomes (6)

Change in Wound Volume From the Time Prior to Application of the Wound Device to the Time Before the Application of STSG and After STSG
Measured: Baseline to 42 days
Length of Stay in Inpatient Unit
Measured: Baseline to 42 days
Patient Pain Rating
Measured: Baseline to 42 days
Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days
Measured: 28 days
Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture
Measured: Baseline to 70 days
Subject Discharge Destination
The facility that the subject is discharged to will be captured.
Measured: Baseline to 70 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201922 Sep 2021

First posted29 Oct 2018
Study start6 Feb 2019
Primary completion22 Sep 2021
Study completion22 Sep 2021

Why it stopped: Business decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Burn WoundStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03723590
Sponsor's protocol ID: MED-2018-DIV31-006
Status last verified: Nov 2021
First submitted: 23 Oct 2018
Last updated: 6 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Burn Wound trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix on Preparing Wounds in Burn Patients for Split-thickness Skin Grafting
ClinicalTrials.gov ID: NCT03723590
Acronym / sponsor ID: MED-2018-DIV31-006
Conditions: Burn Wound
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision
Enrolment: 5 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Study start: 6 Feb 2019 (actual)
Primary completion: 22 Sep 2021 (actual)
Study completion: 22 Sep 2021 (actual)
First posted: 29 Oct 2018 (actual)
Results: Posted 1 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Esterified hyaluronic acid matrix	Experimental	Device: Esterified Hyaluronic Acid Matrix

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Has a wound originating from a thermal or electrical burn
Target burn area is less than 20% of TBSA
Target burn wound is greater than 0.5% of TBSA
Patient has undergone escharectomy procedure or will undergo escharectomy on the target burn and resulting wound will likely need a split thickness skin graft, but wound site is not immediately ready for grafting
For patients with diabetes, an A1C hemoglobin level between 11 percent (taken within 90 days)

Key exclusion criteria (6 listed)

Current active diagnosis of substance abuse, per the Investigator
Patient currently taking non-inhaled corticosteroids
Patient needs or is likely to need negative pressure wound therapy of the target wound after application of Hyalomatrix Wound Device
Patient is pregnant, planning to become pregnant during study period, or breastfeeding
Unstable medical condition as determined by the site investigator

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
Esterified Hyaluronic Acid MatrixA non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss	Device	Esterified hyaluronic acid matrix

Primary outcome

Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft
Time frame: Baseline to 42 days

6 secondary outcomes

Change in Wound Volume From the Time Prior to Application of the Wound Device to the Time Before the Application of STSG and After STSG
Time frame: Baseline to 42 days
Length of Stay in Inpatient Unit
Time frame: Baseline to 42 days
Patient Pain Rating
Time frame: Baseline to 42 days
Proportion of Split Thickness Skin Graft Take for the Wound at 28 Days
Time frame: 28 days
Proportion of Patients Who Develop an Infection of the Target Wound at Any Time Per Confirmation With Culture
Time frame: Baseline to 70 days
Subject Discharge Destination
Time frame: Baseline to 70 days

Results and safety

Results posted to the registry on 1 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esterified Hyaluronic Acid Matrix	5	0

Primary outcome: Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft

Time frame: Baseline to 42 days

Population analysed: Study was stopped due to business decision and data was not collected for analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study stopped due to business decision. Baseline, data & Subject packets were not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esterified Hyaluronic Acid Matrix	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Due to a business decision with the pandemic it was decided to terminate this study and data was never collected from the site or analyzed for this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Burn Wound

RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
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Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis

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.

Questions about this trial

What is this clinical trial studying?

A study testing Esterified Hyaluronic Acid Matrix in people with Burn Wound, run by Medline Industries.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Days From Initial Application of Wound Matrix to Approval of Wound to Receive a Split Thickness Skin Graft (time frame: Baseline to 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03723590.

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 6 Sep 2023.