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Effectiveness of topical hydrogel containing sodium valproate on second degree burn wound healing

Investigating the effectiveness of topical hydrogel containing sodium valproate on second degree burn wound healing in patients referred to the burn department of Ashair Hospital: a randomized controlled, double-blinded clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230410057871N7
Enrollment
50
Registered
2025-09-05
Start date
2025-08-05
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Burn of Second Degree. Burn of second degree, body region unspecified

Interventions

Intervention 1: Intervention group: In the intervention group (n=50), in addition to standard burn treatment (burn ointment prescribed by a physician (1% silver sulfadiazine ointment, Sobhan Daru Comp

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: age 18 to 60 years 20-30% total body surface area (TBSA) burn percentage informed consent to participate in the study second-degree burn wound less than 6 hours elapsed from the time of burn occurrence to the time the patient referred to the medical center hospitalization within 24 hours after the burn body mass index 18.5-30 kg/m2 absence of inflammation-related diseases including autoimmune patients, heart, liver, and kidney problems non-pregnant female samples wound without infection or trauma

Exclusion criteria

Exclusion criteria: Undergoing other treatments that could affect recovery history of malignancy insulin-dependent diabetes before admission or other concurrent conditions that could compromise their wound recovery failure to complete treatment severe psychiatric problems expiring during the study people with 1st degree burns due to no need for specific treatment and recovery with routine care and 3rd and 4th degree burns pregnancy immunodeficiency such as HIV infection and drug users participants with sole burns due to difficulty in measuring body weight participants with burns to the face and hands people with respiratory, digestive and malabsorption disorders

Design outcomes

Primary

MeasureTime frame
Wound healing. Timepoint: before intervention and 7, 14, 21, 28 days after intervention. Method of measurement: This is done using a cloth that is placed over the wound after it has been cleaned and dried. A sample showing the shape of the wound is then placed on a grid table (the length of each small square is 0.25 cm). The wound area and the speed of wound healing will be calculated using the following.

Secondary

MeasureTime frame
Hospital stay. Timepoint: Time of discharge will be noted. Method of measurement: Hospital Discharge Document.;Albumin, CRP, Ferritin serum levels. Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: ELISA kit.;Histopathology assessment. Timepoint: 2, 4 weeks after intervention. Method of measurement: Sections are cut and stained with hematoxylin and eosin (HE) and Masson's trichrome.;Immunohistochemistry (IHC). Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: IHC staining are sample preparation (tissue collection, fixation, embedding, sectioning), deparaffinization, antigen retrieval, blocking, primary and secondary antibody application, detection and visualization, and counterstaining.;Local pain assessment. Timepoint: before intervention and 7, 14, 28 days after intervention. Method of measurement: Based on the NRS scale, which scores from 0 to 10.;Side effects. Timepoint: Every monitoring time in 7, 14, 28 days after embarking on intervention. Method of measurement: Using a checklist to check for complications such as wound infection, bleeding, pain, and skin necrosis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArian Karimi Rouzbahani

Lorestan University of Medical Sciences

ariankarimi1998@gmail.com+98 930 675 7977

Outcome results

None listed

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