Burn InjuriesBURN-MICRONCT07209007
Dynamics of Dysbiosis in the Skin and Gut Microbiome of Burn Patients
An observational study of Burn Injuries and Skin Disease, run by Cho Yoon soo at 1 site in South Korea.
Trial summary
This prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Burn Injuries, Skin Disease, Microbiome
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll 600 adult burn patients aged 19 to 65 years who have experienced partial- or full-thickness burns. Participants will be recruited from the Burn Center at Hallym University Hangang Sacred Heart Hospital. All participants must provide written informed consent.
Who may be able to join
- Adults aged 19 to 65 years
- Patients with partial- or full-thickness burns whose wounds have completely healed following debridement, grafting, or conservative treatment
- Ability to understand study objectives and provide written informed consent
Who cannot join
- Use of systemic or topical antibiotics, probiotics, steroids, or immunosuppressants within 2 weeks prior to sample collection
- Pregnancy or breastfeeding
- Chronic skin diseases (e.g., psoriasis, eczema) or systemic illnesses affecting the skin microbiome
- Active infections at the sampling site
- Any medical condition judged by the investigator to make participation inappropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Hangang Sacred Heart Hospital
Seoul, 07247
Yoon Soo Cho, MD, PhD, +82-2-2639-5730, yschorm@hallym.ac.kr
About this study
Official title: An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients
This prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Burn injuries are known to induce systemic physiological and immune responses that may lead to widespread microbial dysbiosis (microbial imbalance) beyond the injured site. However, the dynamics of microbial community changes in both burned and non-burned skin, as well as the gut, remain poorly understood.
In this study, a total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. For burn patients, skin swabs from burned scars and matched non-burned skin, stool samples, and physiological skin measurements will be collected at multiple time points (baseline, 3 months, 6 months, 12 months, and 24 months). Healthy controls will provide skin and stool samples at baseline only.
Read more
Microbial profiling will be performed using 16S ribosomal RNA (rRNA) gene sequencing, and functional prediction will be analyzed using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Physiological skin-barrier measurements, including transepidermal water loss (TEWL), hydration, pH, erythema, and elasticity, will be assessed using standardized instruments. Blood biomarkers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), will also be measured.
The findings of this study will improve our understanding of burn-related microbial dysbiosis, provide insights into microbiome-driven skin-barrier recovery, and inform potential therapeutic strategies for long-term burn care.
Read the detailed description
This is a prospective, observational cohort study conducted at the Burn Institute of Hallym University Hangang Sacred Heart Hospital. The study aims to characterize temporal changes in the skin and gut microbiome of burn patients compared with healthy controls and to identify potential links between microbiome dynamics, skin-barrier recovery, and systemic immune responses.
A total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. Burn patients will be followed longitudinally for 24 months, with sample collection and clinical measurements performed at baseline (within 7 days after hospital admission), 3 months, 6 months, 12 months, and 24 months after injury. Healthy controls will provide single-timepoint samples for comparison.
Sample Collection Skin Microbiome: Swabs will be collected from burned scars and matched non-burned skin sites.
Gut Microbiome: Stool samples will be collected for 16S ribosomal RNA (rRNA) gene sequencing.
Skin Physiological Measurements: Transepidermal water loss (TEWL), hydration, erythema, melanin index, elasticity, and pH levels will be measured using standardized instruments (Corneometer®, Tewameter®, Mexameter®, Cutometer®, and pH meter).
Blood Biomarkers: Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin-6 (IL-6), and other systemic inflammatory markers will be analyzed.
Microbiome Profiling DNA extraction and 16S rRNA gene sequencing will be performed using Illumina sequencing platforms. Bioinformatic processing will be conducted using the Quantitative Insights Into Microbial Ecology 2 (QIIME2) pipeline. Functional prediction of microbial metabolic pathways will be analyzed with Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Beta diversity and alpha diversity indices will be calculated, and taxonomic differences between groups will be assessed using Linear Discriminant Analysis Effect Size (LEfSe).
Clinical Relevance Microbiome dysbiosis (microbial imbalance) after burn injury may extend beyond local wounds and affect non-burned skin and the gut, contributing to impaired skin-barrier function, immune dysregulation, and delayed recovery. Understanding these relationships may help develop microbiome-targeted therapeutic interventions, improve wound healing, and optimize long-term patient care.
- Conditions
- Burn Injuries, Skin Disease, Microbiome, Microbiome Dysbiosis
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Burn Injury, Skin Microbiome, Gut Microbiome, Dysbiosis, 16S rRNA Sequencing
- Medical subject headings
- Burns, Skin Diseases, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is an observational cohort study with no interventions administered. Skin swabs, stool samples, blood samples, and skin physiological measurements will be collected at baseline, 3, 6, 12, and 24 months after burn injury to investigate longitudinal changes in the skin and gut microbiome.
| Study group | Role | What they receive |
|---|---|---|
| Burn Patients Cohort | This cohort includes 600 adult burn patients who experienced partial- or full-thickness burns. Participants will provide skin swabs, stool samples, blood samples, and skin physiological measurements at baseline, 3, 6, 12, and 24 months after injury. The primary objective is to investigate longitudinal changes in the skin and gut microbiome and their association with skin barrier recovery and systemic inflammation. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Microbiome Diversity
Alpha and beta diversity indices of the skin microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline.
Unit of Measure: Shannon diversity index (unitless)
Measured: Baseline, 3, 6, 12, and 24 months after burn injury
Change in Gut Microbiome Diversity
Alpha and beta diversity indices of the gut microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline.
Unit of Measure: Shannon diversity index (unitless)
Measured: Baseline, 3, 6, 12, and 24 months after burn injury
Secondary outcomes (6)
Functional Prediction of Microbiome
Predicted microbial functional pathways will be identified using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2) and the Kyoto Encyclopedia of Genes and Genomes (KEGG) database.
Unit of Measure: Relative pathway abundance (percentage)
Measured: Baseline, 3, 6, 12, 24 months
Transepidermal Water Loss (TEWL)
TEWL will be measured using Tewameter® to assess skin barrier integrity.
Unit of Measure: grams per square meter per hour (g/m²/h)
Measured: Baseline, 3, 6, 12, 24 months
Skin Hydration
Skin hydration will be measured using Corneometer® to assess stratum corneum moisture levels.
Unit of Measure: arbitrary units (a.u.)
Measured: Baseline, 3, 6, 12, and 24 months after burn injury
Skin Elasticity
Skin elasticity will be measured using Cutometer® to assess biomechanical recovery of scar tissue.
Unit of Measure: arbitrary units (a.u.)
Measured: Baseline, 3, 6, 12, and 24 months after burn injury
Serum C-Reactive Protein (CRP) Concentration
Serum CRP concentration will be measured as a systemic inflammatory biomarker.
Unit of Measure: milligrams per liter (mg/L)
Measured: Baseline, 3, 6, 12, 24 months
Erythrocyte Sedimentation Rate (ESR)
ESR will be measured from peripheral blood samples to assess systemic inflammation.
Unit of Measure: millimeters per hour (mm/hr)
Measured: Baseline, 3, 6, 12, and 24 months after burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start15 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Burn InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cho Yoon soo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cho Yoon soo, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209007
- Sponsor's protocol ID
- HG 2025-023
- Other IDs
- HG2025-023
- Acronym
- BURN-MICRO
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study involves sensitive clinical and microbiome information from burn patients, and the IRB-approved protocol does not include explicit consent for data sharing.
Publications
Jung Y, Cui HS, Joo SY, Lee EK, Seo CH, Cho YS. Sex differences in the skin microbiome of burn scars. Wound Repair Regen. 2023 Jul-Aug;31(4):547-558. doi: 10.1111/wrr.13088. Epub 2023 Jun 24.
PubMed 37129034Jung Y, Cui HS, Lee EK, Joo SY, Seo CH, Cho YS. Effects of Factors Influencing Scar Formation on the Scar Microbiome in Patients with Burns. Int J Mol Sci. 2023 Nov 6;24(21):15991. doi: 10.3390/ijms242115991.
PubMed 37958976Ersanli C, Tzora A, Voidarou CC, Skoufos S, Zeugolis DI, Skoufos I. Biodiversity of Skin Microbiota as an Important Biomarker for Wound Healing. Biology (Basel). 2023 Aug 30;12(9):1187. doi: 10.3390/biology12091187.
PubMed 37759587Corcione S, Lupia T, De Rosa FG; Host and Microbiota Interaction Study Group (ESGHAMI) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Microbiome in the setting of burn patients: implications for infections and clinical outcomes. Burns Trauma. 2020 Aug 14;8:tkaa033. doi: 10.1093/burnst/tkaa033. eCollection 2020.
PubMed 32821744Nakai K, Kubota Y, Soma GI, Kohchi C. The Effect of Lipopolysaccharide-containing Moisturizing Cream on Skin Care in Patients With Mild Atopic Dermatitis. In Vivo. 2019 Jan-Feb;33(1):109-114. doi: 10.21873/invivo.11446.
PubMed 30587610Ogawa R, Akaishi S. Endothelial dysfunction may play a key role in keloid and hypertrophic scar pathogenesis - Keloids and hypertrophic scars may be vascular disorders. Med Hypotheses. 2016 Nov;96:51-60. doi: 10.1016/j.mehy.2016.09.024. Epub 2016 Sep 28.
PubMed 27959277Gimblet C, Meisel JS, Loesche MA, Cole SD, Horwinski J, Novais FO, Misic AM, Bradley CW, Beiting DP, Rankin SC, Carvalho LP, Carvalho EM, Scott P, Grice EA. Cutaneous Leishmaniasis Induces a Transmissible Dysbiotic Skin Microbiota that Promotes Skin Inflammation. Cell Host Microbe. 2017 Jul 12;22(1):13-24.e4. doi: 10.1016/j.chom.2017.06.006. Epub 2017 Jun 29.
PubMed 28669672Liu SH, Huang YC, Chen LY, Yu SC, Yu HY, Chuang SS. The skin microbiome of wound scars and unaffected skin in patients with moderate to severe burns in the subacute phase. Wound Repair Regen. 2018 Mar;26(2):182-191. doi: 10.1111/wrr.12632. Epub 2018 May 21.
PubMed 29663582Baldwin HE, Bhatia ND, Friedman A, Eng RM, Seite S. The Role of Cutaneous Microbiota Harmony in Maintaining a Functional Skin Barrier. J Drugs Dermatol. 2017 Jan 1;16(1):12-18.
PubMed 28095528Lehtimaki J, Karkman A, Laatikainen T, Paalanen L, von Hertzen L, Haahtela T, Hanski I, Ruokolainen L. Patterns in the skin microbiota differ in children and teenagers between rural and urban environments. Sci Rep. 2017 Mar 31;7:45651. doi: 10.1038/srep45651.
PubMed 28361981Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
PubMed 19478181Rogers MB, Firek B, Shi M, Yeh A, Brower-Sinning R, Aveson V, Kohl BL, Fabio A, Carcillo JA, Morowitz MJ. Disruption of the microbiota across multiple body sites in critically ill children. Microbiome. 2016 Dec 29;4(1):66. doi: 10.1186/s40168-016-0211-0.
PubMed 28034303Alekseyenko AV, Perez-Perez GI, De Souza A, Strober B, Gao Z, Bihan M, Li K, Methe BA, Blaser MJ. Community differentiation of the cutaneous microbiota in psoriasis. Microbiome. 2013 Dec 23;1(1):31. doi: 10.1186/2049-2618-1-31.
PubMed 24451201
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients
- ClinicalTrials.gov ID
- NCT07209007
- Acronym / sponsor ID
- BURN-MICRO / HG 2025-023
- Conditions
- Burn Injuries, Skin Disease, Microbiome, Microbiome Dysbiosis
- Keywords
- Burn Injury, Skin Microbiome, Gut Microbiome, Dysbiosis, 16S rRNA Sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cho Yoon sooUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Oct 2025 (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 prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Burn injuries are known to induce systemic physiological and immune responses that may lead to widespread microbial dysbiosis (microbial imbalance) beyond the injured site. However, the dynamics of microbial community changes in both burned and non-burned skin, as well as the gut, remain poorly understood.
In this study, a total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. For burn patients, skin swabs from burned scars and matched non-burned skin, stool samples, and physiological skin measurements will be collected at multiple time points (baseline, 3 months, 6 months, 12 months, and 24 months). Healthy controls will provide skin and stool samples at baseline only.
Microbial profiling will be performed using 16S ribosomal RNA (rRNA) gene sequencing, and functional prediction will be analyzed using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Physiological skin-barrier measurements, including transepidermal water loss (TEWL), hydration, pH, erythema, and elasticity, will be assessed using standardized instruments. Blood biomarkers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), will also be measured.
The findings of this study will improve our understanding of burn-related microbial dysbiosis, provide insights into microbiome-driven skin-barrier recovery, and inform potential therapeutic strategies for long-term burn care.
Detailed description
This is a prospective, observational cohort study conducted at the Burn Institute of Hallym University Hangang Sacred Heart Hospital. The study aims to characterize temporal changes in the skin and gut microbiome of burn patients compared with healthy controls and to identify potential links between microbiome dynamics, skin-barrier recovery, and systemic immune responses.
A total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. Burn patients will be followed longitudinally for 24 months, with sample collection and clinical measurements performed at baseline (within 7 days after hospital admission), 3 months, 6 months, 12 months, and 24 months after injury. Healthy controls will provide single-timepoint samples for comparison.
Sample Collection Skin Microbiome: Swabs will be collected from burned scars and matched non-burned skin sites.
Gut Microbiome: Stool samples will be collected for 16S ribosomal RNA (rRNA) gene sequencing.
Skin Physiological Measurements: Transepidermal water loss (TEWL), hydration, erythema, melanin index, elasticity, and pH levels will be measured using standardized instruments (Corneometer®, Tewameter®, Mexameter®, Cutometer®, and pH meter).
Blood Biomarkers: Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin-6 (IL-6), and other systemic inflammatory markers will be analyzed.
Microbiome Profiling DNA extraction and 16S rRNA gene sequencing will be performed using Illumina sequencing platforms. Bioinformatic processing will be conducted using the Quantitative Insights Into Microbial Ecology 2 (QIIME2) pipeline. Functional prediction of microbial metabolic pathways will be analyzed with Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Beta diversity and alpha diversity indices will be calculated, and taxonomic differences between groups will be assessed using Linear Discriminant Analysis Effect Size (LEfSe).
Clinical Relevance Microbiome dysbiosis (microbial imbalance) after burn injury may extend beyond local wounds and affect non-burned skin and the gut, contributing to impaired skin-barrier function, immune dysregulation, and delayed recovery. Understanding these relationships may help develop microbiome-targeted therapeutic interventions, improve wound healing, and optimize long-term patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn Patients Cohort | – | Other: No Intervention: Observational CohortThis cohort includes 600 adult burn patients who experienced partial- or full-thickness burns. Participants will provide skin swabs, stool samples, blood samples, and skin physiological measurements at baseline, 3, 6, 12, and 24 months after injury. The primary objective is to investigate longitudinal changes in the skin and gut microbiome and their association with skin barrier recovery and systemic inflammation. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll 600 adult burn patients aged 19 to 65 years who have experienced partial- or full-thickness burns. Participants will be recruited from the Burn Center at Hallym University Hangang Sacred Heart Hospital. All participants must provide written informed consent.
Key inclusion criteria (3 listed)
- Adults aged 19 to 65 years
- Patients with partial- or full-thickness burns whose wounds have completely healed following debridement, grafting, or conservative treatment
- Ability to understand study objectives and provide written informed consent
Key exclusion criteria (5 listed)
- Use of systemic or topical antibiotics, probiotics, steroids, or immunosuppressants within 2 weeks prior to sample collection
- Pregnancy or breastfeeding
- Chronic skin diseases (e.g., psoriasis, eczema) or systemic illnesses affecting the skin microbiome
- Active infections at the sampling site
- Any medical condition judged by the investigator to make participation inappropriate
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 |
|---|---|---|
| No Intervention: Observational CohortThis is an observational cohort study with no interventions administered. Skin swabs, stool samples, blood samples, and skin physiological measurements will be collected at baseline, 3, 6, 12, and 24 months after burn injury to investigate longitudinal changes in the skin and gut microbiome. | Other | Burn Patients Cohort |
Primary outcome
Change in Skin Microbiome Diversity
Time frame: Baseline, 3, 6, 12, and 24 months after burn injury
Alpha and beta diversity indices of the skin microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline. Unit of Measure: Shannon diversity index (unitless)
Change in Gut Microbiome Diversity
Time frame: Baseline, 3, 6, 12, and 24 months after burn injury
Alpha and beta diversity indices of the gut microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline. Unit of Measure: Shannon diversity index (unitless)
6 secondary outcomes
Functional Prediction of Microbiome
Time frame: Baseline, 3, 6, 12, 24 months
Transepidermal Water Loss (TEWL)
Time frame: Baseline, 3, 6, 12, 24 months
Skin Hydration
Time frame: Baseline, 3, 6, 12, and 24 months after burn injury
Skin Elasticity
Time frame: Baseline, 3, 6, 12, and 24 months after burn injury
Serum C-Reactive Protein (CRP) Concentration
Time frame: Baseline, 3, 6, 12, 24 months
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, 3, 6, 12, and 24 months after burn injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 37129034Jung Y, Cui HS, Joo SY, Lee EK, Seo CH, Cho YS. Sex differences in the skin microbiome of burn scars. Wound Repair Regen. 2023 Jul-Aug;31(4):547-558. doi: 10.1111/wrr.13088. Epub 2023 Jun 24.
- Background: PubMed 37958976Jung Y, Cui HS, Lee EK, Joo SY, Seo CH, Cho YS. Effects of Factors Influencing Scar Formation on the Scar Microbiome in Patients with Burns. Int J Mol Sci. 2023 Nov 6;24(21):15991. doi: 10.3390/ijms242115991.
- Background: PubMed 37759587Ersanli C, Tzora A, Voidarou CC, Skoufos S, Zeugolis DI, Skoufos I. Biodiversity of Skin Microbiota as an Important Biomarker for Wound Healing. Biology (Basel). 2023 Aug 30;12(9):1187. doi: 10.3390/biology12091187.
- Background: PubMed 32821744Corcione S, Lupia T, De Rosa FG; Host and Microbiota Interaction Study Group (ESGHAMI) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Microbiome in the setting of burn patients: implications for infections and clinical outcomes. Burns Trauma. 2020 Aug 14;8:tkaa033. doi: 10.1093/burnst/tkaa033. eCollection 2020.
- Background: PubMed 30587610Nakai K, Kubota Y, Soma GI, Kohchi C. The Effect of Lipopolysaccharide-containing Moisturizing Cream on Skin Care in Patients With Mild Atopic Dermatitis. In Vivo. 2019 Jan-Feb;33(1):109-114. doi: 10.21873/invivo.11446.
- Background: PubMed 27959277Ogawa R, Akaishi S. Endothelial dysfunction may play a key role in keloid and hypertrophic scar pathogenesis - Keloids and hypertrophic scars may be vascular disorders. Med Hypotheses. 2016 Nov;96:51-60. doi: 10.1016/j.mehy.2016.09.024. Epub 2016 Sep 28.
- Background: PubMed 28669672Gimblet C, Meisel JS, Loesche MA, Cole SD, Horwinski J, Novais FO, Misic AM, Bradley CW, Beiting DP, Rankin SC, Carvalho LP, Carvalho EM, Scott P, Grice EA. Cutaneous Leishmaniasis Induces a Transmissible Dysbiotic Skin Microbiota that Promotes Skin Inflammation. Cell Host Microbe. 2017 Jul 12;22(1):13-24.e4. doi: 10.1016/j.chom.2017.06.006. Epub 2017 Jun 29.
- Background: PubMed 29663582Liu SH, Huang YC, Chen LY, Yu SC, Yu HY, Chuang SS. The skin microbiome of wound scars and unaffected skin in patients with moderate to severe burns in the subacute phase. Wound Repair Regen. 2018 Mar;26(2):182-191. doi: 10.1111/wrr.12632. Epub 2018 May 21.
- Background: PubMed 28095528Baldwin HE, Bhatia ND, Friedman A, Eng RM, Seite S. The Role of Cutaneous Microbiota Harmony in Maintaining a Functional Skin Barrier. J Drugs Dermatol. 2017 Jan 1;16(1):12-18.
- Background: PubMed 28361981Lehtimaki J, Karkman A, Laatikainen T, Paalanen L, von Hertzen L, Haahtela T, Hanski I, Ruokolainen L. Patterns in the skin microbiota differ in children and teenagers between rural and urban environments. Sci Rep. 2017 Mar 31;7:45651. doi: 10.1038/srep45651.
- Background: PubMed 19478181Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
- Background: PubMed 28034303Rogers MB, Firek B, Shi M, Yeh A, Brower-Sinning R, Aveson V, Kohl BL, Fabio A, Carcillo JA, Morowitz MJ. Disruption of the microbiota across multiple body sites in critically ill children. Microbiome. 2016 Dec 29;4(1):66. doi: 10.1186/s40168-016-0211-0.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study involves sensitive clinical and microbiome information from burn patients, and the IRB-approved protocol does not include explicit consent for data sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Injuries and Skin Disease, run by Cho Yoon soo at 1 site in South Korea.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. 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 South Korea. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoon Soo Cho, MD, PhD (+82-2-2639-5730, yschorm@hallym.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Microbiome Diversity (time frame: Baseline, 3, 6, 12, and 24 months after burn injury). The study lists 2 primary outcomes in all. 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 NCT07209007, which also lists 13 linked publications.
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 Oct 2025.