Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • Dermatology
  • Dermatology News
  • StrataGraft for...

StrataGraft for treatment of thermal burns gets FDA approval

Written By : Hina Zahid |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2021-06-16T10:45:53+05:30  |  Updated On 16 Jun 2021 12:00 PM IST
StrataGraft for treatment of thermal burns gets FDA approval
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

USA: The U.S. Food and Drug Administration has given approval to StrataGraft for the treatment of adult patients with thermal burns. Thermal burns are typically caused by direct contact with an external heat source such as steam, scalding water, hot surfaces or fire.

StrataGraft is produced from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered construct (a cellularized scaffold). It is for topical application, placed onto the burn by a healthcare provider. Over time, the patient's skin cells should grow to replace the skin cells lost as a result of the burn. Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting.

Bedminister's StrataGraft was designed for the treatment of thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial-thickness burns).

"Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient return to the highest level of functionality and independence possible, while improving the overall quality of life," said Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research. "This approval provides health care professionals a novel way to treat burn wounds."

For many deep burns, treatment frequently involves the removal of the damaged, burned skin and replacement with a skin graft. Skin grafts are often the patient's own healthy skin taken from their body and moved to the burned area to help it heal. This procedure, called an autograft, leaves a new wound where the healthy skin was removed.

The effectiveness and safety of StrataGraft are based on two randomized clinical studies involving a total of 101 adult patients with deep partial‑thickness thermal burns. In both studies, two deep partial-thickness burn wounds of comparable area and depth on each patient were identified and randomized to receive either a single topical application of StrataGraft or autograft. The effectiveness is demonstrated by the percentage of StrataGraft treatment sites that achieved a complete wound closure, and the significantly decreased need for autografts at the StrataGraft treatment sites.

Common side effects reported by patients who received StrataGraft in clinical studies were pruritus (itching), blisters, hypertrophic scar, and impaired healing (stalled healing process) at the treatment site. Overall, the safety profile of StrataGraft regarding wound‑related events, included erythema (redness), swelling, local warmth and wound site infections, was similar to that of autografting in these studies. There were no reports of rejection of StrataGraft in the clinical studies.

The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for this indication.

StrataGraft was developed in conjunction with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

Since the human keratinocyte cells were grown with mouse cells during initial stages of product development, StrataGraft is formally considered to be a xenotransplantation product (involving tissues or cells belonging to different species). Mouse cells are no longer used in the final manufacturing process. Due to StrataGraft containing cells from human donors and animal-derived materials, and because animal cells were used in early stages of product development, there is a risk of transmission of infectious diseases or agents although at this time transmission of infectious diseases or agents by StrataGraft has not been reported.

The FDA granted approval to Stratatech, a Mallinckrodt company.


thermal burnsfda approvedUS Food and Drug Administration
Source : US FDA
Hina Zahid
Hina Zahid

    Hina Zahid Joined Medical Dialogue in 2017 with a passion to work as a Reporter. She coordinates with various national and international journals and association and covers all the stories related to Medical guidelines, Medical Journals, rare medical surgeries as well as all the updates in the medical field. Email: editorial@medicaldialogues.in. Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

    Show Full Article
    Next Story

    Editorial

    Featured image representing thinking

    Is Pharma Marketing Going Through "Thinking Recession"?

    Beyond BMI: Why Pioglitazone Deserves a Place in Managing Thin-Fat Type 2 Diabetes in India

    Beyond BMI: Why Pioglitazone Deserves a Place in Managing 'Thin-Fat' Type 2 Diabetes in India

    How to Improve Adherence in Hypertensive Patients? Bridging the Gap with CONNECT Tool

    How to Improve Adherence in Hypertensive Patients? Bridging the Gap with CONNECT Tool

    Vestibular Migraine: Clinical Update and Role of Buccal Prochlorperazine

    Vestibular Migraine: Clinical Update and Role of Buccal Prochlorperazine

    U.S. FDA Drug Safety Alert: Warning Issued for Severe Itching After Stopping Long-Term Cetirizine or Levocetirizine Use

    U.S. FDA Drug Safety Alert: Warning Issued for Severe Itching After Stopping Long-Term Cetirizine or...

    View All

    Journal Club Today

    Overemphasis on Weight Loss May Harm Patients: BMJ Study Finds

    Overemphasis on Weight Loss May Harm Patients: BMJ Study Finds

    View All

    Health News Today

    Health Bulletin 28/June/2025

    Health Bulletin 28/June/2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok