Investigation of the effect of hydrogel wound dressing based on polyacrylic acid and xanthan gum in the treatment of burn injury

Evaluation of safety and efficacy of hydrogel wound dressing based on polyacrylic acid and xanthan gums in patients with 2nd thickness burns (Clinical trial phase II)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161001030072N4

Enrollment

Registered

2023-10-04

Start date

2023-10-02

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

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

Interventions

Intervention 1: Intervention group: Before strarting the study, patients wound are examined by a doctor based on a checklist. Wounds are first washed with normal saline, Then a hydrogel dressing based

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Thermal burns with flame or boiling water Second degree burns Burn percent range Between 20-50% Refer to the treatment center within less than 24 hours after the burn Normal hemoglobin and total protein levels are normal Male or female patients in age range 18 to 65 years Written consent form by the patients Body mass index between 18-30 kg/m2

Exclusion criteria

Exclusion criteria: Having background diseases ( anemia, diabetes, cardiovascular diseases, immunodeficiency disorder) Lactating women Pregnant women

Design outcomes

Primary

Measure	Time frame
Local out comes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the hydrogel 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 hydrogel wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points.	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Infection. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7,14, and 28 days after applying the hydrogel wound dressing. Method of measurement: Based on examination done by evaluators.;Hospital stay. Timepoint: At discharge. Method of measurement: Based on patients' files.;Total fluid requirement. Timepoint: At discharge. Method of measurement: Based on patients' files.;Graft to TBSA (total body surface area) percent ratio. Timepoint: At the admission. Method of measurement: Measurements based on Wallace criteria.	—

Measure

Time frame

Infection. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7,14, and 28 days after applying the hydrogel wound dressing. Method of measurement: Based on examination done by evaluators.;Hospital stay. Timepoint: At discharge. Method of measurement: Based on patients' files.;Total fluid requirement. Timepoint: At discharge. Method of measurement: Based on patients' files.;Graft to TBSA (total body surface area) percent ratio. Timepoint: At the admission. Method of measurement: Measurements based on Wallace criteria.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Mobayen

Rasht University of Medical Sciences

Maziar.mobayen@gmail.com+98 13 3336 8540

Outcome results

None listed

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