Effectiveness of Alovera Gel vs 1% Silver Sulfadiazine in Superficial Partial Thickness Burn Patients in Pediatric Population.

This prospective randomized controlled study aims to compare the effectiveness of Aloe vera gel versus 1% silver sulfadiazine in the treatment of superficial and superficial partial-thickness burns in the pediatric population. Burn injuries are among the most common causes of morbidity in children, and optimal topical treatment is important for pain control, prevention of infection, and rapid wound healing.

Pediatric patients presenting with superficial and superficial partial-thickness burns will be enrolled and allocated into two treatment groups. One group will receive topical Aloe vera gel, while the other group will receive 1% silver sulfadiazine dressing according to standard burn care protocols. Patients will be followed regularly to assess wound healing progress, pain, infection rate, duration of healing, frequency of dressing changes, and any treatment-related complications. The primary outcome will be time to complete wound healing, while secondary outcomes will include pain score, infection rate, hospital stay, and scar formation.

Study Overview

• Status: Completed
• Conditions: Superficial and Superficial Partial Thickness Burns
• Intervention / Treatment: Other: Alovera gel; Drug: Silver sulfadiazine 1%cream

Detailed Description

Burn injuries are a significant cause of morbidity among the pediatric population and require effective topical therapy to promote wound healing, prevent infection, reduce pain, and minimize treatment cost. Silver sulfadiazine 1% cream is commonly used as a standard topical antimicrobial agent for superficial burns; however, delayed wound healing and frequent dressing requirements have encouraged the search for alternative therapies. Aloe vera has demonstrated anti-inflammatory, antimicrobial, soothing, and wound-healing properties in previous studies and may serve as an effective and economical alternative in burn management.

This randomized controlled trial will be conducted at The Children's Hospital & Institute of Child Health Lahore over a duration of one year. A total of 60 pediatric patients aged 1 to 18 years presenting with superficial and superficial partial-thickness burns involving 1% to 25% total body surface area (TBSA) will be enrolled in the study. Patients will be randomly allocated into two groups by coin toss/lottery method. One group will receive topical Aloe vera gel dressing, while the second group will receive 1% silver sulfadiazine dressing. Dressings will be applied three times daily according to institutional burn care protocol.

Patients will be followed for a period of 14 days to assess treatment outcomes. The primary outcome measure will be the degree and rate of re-epithelialization of burn wounds. Secondary outcome measures will include pain relief, infection rate, and cost effectiveness of treatment. Patients with burns deeper than superficial partial-thickness burns, including deep second-degree and third-degree burns, as well as patients requiring surgical intervention or presenting with major associated comorbidities, will be excluded from the study.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • UCHSLahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - Patients aged 1 to 18 years
• Both male and female patients
• Superficial and superficial partial-thickness burns
• Burn extent involving 1% to 25% total body surface area (TBSA)
• Presentation within acute phase of burn injury

Exclusion Criteria:

• - Deep partial-thickness (deep second-degree) or third-degree burns
• Patients requiring surgical intervention (skin grafting)
• Infected burns at presentation
• Patients with major comorbidities affecting wound healing (e.g., immunodeficiency, diabetes mellitus)
• Known hypersensitivity to Aloe vera or silver sulfadiazine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm-1: Alovera group; Alovera gel applied 3 times daily until complete repithelization	Other: Alovera gel; Alovera gel applied 3 times daily until complete repithelization
Other: Silver sulfadiazine 1% topical cream; Silver sulfadiazine applied 3 times daily until complete repithelization	Drug: Silver sulfadiazine 1%cream; Silver sulfadiazine applied 3 times daily until complete repithelization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of repithelization	The primary outcome is the degree and rate of re-epithelialization of superficial and superficial partial-thickness burn wounds in pediatric patients. Wound healing will be assessed clinically by measuring percentage of wound closure and epithelial regeneration over a follow-up period of 14 days or until complete healing, whichever occurs earlier	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Pain relief will be assessed using age-appropriate pain scoring systems (FLACC scale for younger children and Visual Analogue Scale for older children). Changes in pain scores will be recorded before and after treatment during the 14-day follow-up period.	14 days
Wound Infection	The incidence of wound infection will be assessed clinically based on signs such as erythema, purulent discharge, increased pain, or fever during the treatment period	14 days
Cost effectiveness	Cost effectiveness will be evaluated by comparing the total cost of treatment in both groups, including dressing materials, frequency of dressing changes, and overall management expenses during the study period.	14 days

Collaborators and Investigators

• Sponsor: University of Child Health Sciences and Children's Hospital, Lahore

Publications and helpful links

General Publications

• Shahzad MN, Ahmed N. Effectiveness of Aloe Vera gel compared with 1% silver sulphadiazine cream as burn wound dressing in second degree burns. J Pak Med Assoc. 2013 Feb;63(2):225-30.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Actual): March 15, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: No/2099/UCHS-CH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pediatric patient data is sensitive Requires strict ethical approval for sharing Most single-center academic RCTs in Pakistan do not share IPD publicly

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No