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Synthetic skin patch could revolutionize burn treatment

NCT ID NCT04090424

Disease control Sponsor: PolyNovo Biomaterials Pty Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new synthetic skin substitute called NovoSorb BTM for treating severe burns. About 150 adults with deep burns covering 3% to 60% of their body will receive either the new matrix or standard care. The goal is to see if the new material helps burns close completely after skin grafting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NovoSorb Biodegradable Temporizing Matrix (BTM) - a synthetic skin substitute
What this could lead to
If successful, this could provide a new, effective option for treating severe burns, potentially improving healing and reducing complications.
What could go wrong
This is a single study with 150 participants, and results may not apply to all burn patients. The device is synthetic and may not integrate as well as natural tissue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed 2. Willing to comply with all study procedures and expects to be available for the duration of the study 3. Male and females ≥ 18 years of age and ≤ 75 years of age 4. Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA). Types of burns include the following: * Scalding including from hot water, cooking oil, grease * Flame * Flash * Contact 5. Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft. 6. The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA 7. Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study. Exclusion Criteria: 1. Has a known hypersensitivity to polyurethane 2. Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash 3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin 4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy 5. Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound 6. For females - has known or suspected pregnancy, planned pregnancy, or during lactation 7. Has exposure to any other investigational agent within the last 6 months 8. Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration 9. Anticipated inability to perform wound care and follow-up procedures 10. Anticipates of a level of non-compliance 11. The use of off-label treatments for full-thickness / deep-dermal burns is not permitted 12. Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives 13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted

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Conditions

The condition(s) this trial relates to.

burn

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Burns

Contacts and locations

Locations

  • Akron Children's Hospital, Burn Center

    Akron, Ohio, 44308, United States

  • Bembde Hospital

    Aurangabad, Maharashtra, India

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Emory University at Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Ganga Medical Centre and Hospitals PVT Ltd

    Coimbatore, Tamil Nadu, India

  • Lehigh Valley Hospital and Health Network

    Allentown, Pennsylvania, 18103, United States

  • Loyola University of Chicago

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02446, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • National Burns Centre

    Mumbai, Maharashtra, India

  • New York Presbyterian Weill Cornell Medicine

    New York, New York, 10065, United States

  • Southern California Regional Burn Center at LAC+USC

    Los Angeles, California, 90033, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The Ohio State University/ Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UW Health University Hospital

    Madison, Wisconsin, 53792, United States

  • University Medical Center, New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Valleywise Health

    Phoenix, Arizona, 85008, United States

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23219, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 24157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.