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Investigating effectiveness of smart biodegradable nanofiber dressing in the treatment of 2nd degree burn wounds

Investigating the safety and effectiveness of smart biodegradable nanofiber dressing in the treatment of deep 2nd degree burn wounds (first and second phase of clinical trial)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231122060138N1
Enrollment
16
Registered
2023-12-03
Start date
2023-12-11
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Second degree burn. Burn and corrosion of head, face, and neck

Interventions

Intervention 1: Intervention group: Randomly, the site of the intervention group will be selected and will receive polymer dressing containing lactic acid and s-caprolactone. Intervention 2: Control g

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult patient between 18 and 65 years old Refer to the treatment center in less than 24 hours Burn percentage ranges from 20-50% Fill out the informed consent form There should be at least 2 recorded records of the investigated variables. Patients should stay in the hospital for at least three days

Exclusion criteria

Exclusion criteria: Having severe hypertension BP=160/90 mmHg High cardiac troponin pregnant women Immune system defect Anticoagulation problems, bleeding disorders, or heart disease

Design outcomes

Primary

MeasureTime frame
Local outcomes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points.;Systemic outcomes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points.

Secondary

MeasureTime frame
Wound healing rate. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7,14, and 28 days after applying the wound dressing. Method of measurement: Based on examination done by evaluators.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmadreza Mobayen

Zanjan University of Medical Sciences

amobaien@yahoo.com-

Outcome results

None listed

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