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The effect of nanofibril adhesives containing plant-based nanohydrogels on burn treatment

Design and production of nanofibril adhesives containing plant-based nanohydrogels for healing and treating wounds caused by second-degree human burns

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250430065544N1
Enrollment
70
Registered
2025-06-02
Start date
2025-07-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn wounds. Burn of second degree of trunk, unspecified site, initial encounter

Interventions

Intervention 1: Nanofibril wound dressing containing plant nanohydrogels is made of natural biopolymers including sodium alginate, chitosan and polyvinyl alcohol (PVA) (main chemical compositionsSodiu

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: High-quality formulation confirmed by quality control tests highly effective formulation patients with 2nd degree burns (no gender or age restrictions)

Exclusion criteria

Exclusion criteria: patient's personal request to withdraw wound infection or sensitivity to the dressing pregnant women patients with liver and kidney failure people taking corticosteroid-containing drugs no evidence of wound healing within 7 days (in this case, the patient is excluded from the study and receives routine treatment with gentamicin ointment)

Design outcomes

Primary

MeasureTime frame
Degree of wound healing: Measured based on the average wound circumference and area in patients receiving placebo on different days (before the study and on days 0, 3, 7, 14 and 21).Changes in wound healing: Comparison of changes in wound healing (based on mean wound perimeter and area) on different days (before the study and on days 0, 3, 7, 14 and 21) between patients in the two study groups. Timepoint: Before the start of the study, day 0, day 3, day 7, day 14, day 21. Method of measurement: Demographic variablesCollected using a questionnaire of demographic information (age, sex, marital status, burn site, burn agent, smoking status). Wound dimensions, including length and width, were measured using calipers to calculate area and depth.Visual Analog Scale (VAS) Assessment: Wound healing was assessed using a visual analog scale (VAS), where a wound specialist analyzed the photographs and classified the wounds into four groups: poor, moderate, good, and excellent. Burn severity and wound size were monitored for 21 days using a VAS scale (0-10).

Secondary

MeasureTime frame
VEGF, TGF-ß? bFGF gene expression level in burn tissues. Timepoint: Before the study and on days 0, 3, 7, 14 and 21. Method of measurement: RNA extraction: Total RNA is extracted from burn tissue of test mice using Trizol and specialized RNA extraction kits, following the appropriate protocol. cDNA synthesis: cDNA is synthesized using the corresponding kits, following the kit protocol. Quantitative PCR: Real-time PCR is used to examine the expression levels of VEGF? bFGF? ß-TGF genes in burn tissues. GAPDH is used as an internal control gene to analyze gene expression levels.;Effect of biopolymer wound dressing containing caron and gentamicin on the expression of genes related to wound healing, including DNMT?,DNMT?A,DNMT?B, miR-34a, miR-145 and NF-kb. Timepoint: Before the study and on days 0, 3, 7, 14 and 21. Method of measurement: RNA extraction: Total RNA is extracted from burn tissue of test mice using Trizol and specialized RNA extraction kits, following the appropriate protocol. cDNA synthesis: cDNA is synthesized using the corresponding kits, following the kit protocol. Quantitative PCR: Real-time PCR is used to examine the expression levels of DNMT?,DNMT?A,DNMT?B ?miR-145 ?miR-34a, and NF-kb genes in burn tissues. GAPDH and U6 is used as an internal control gene to analyze gene expression levels.;The effect of biopolymer wound dressing containing caron and gentamicin on changes in overall DNA methylation. Timepoint: Before the study and on days 0, 3, 7, 14 and 21. Method of measurement: After DNA extraction from wound tissue, global DNA methylation changes induced by carotenoids and gentamicin are measured using the Flash Methyl kit.;Biopolymer cytotoxicity. Timepoint: Before the study and on days 0, 3, 7, 14 and 21. Method of measurement: Cell viability assay, cell growth and survival are assessed using the MTT assay. Skin cells including HFFF2 fibroblast cells and normal lymphocytes isolated from human blood are obtained from the Pasteur Institute of

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Moradi Sarabi

Khoram-Abad University of Medical Sciences

mostafa.moradi@gmail.com+98 66 3330 0661

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026