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OpenTrials
Completed

NCT Number: NCT07716605

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.

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHSLahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver sulfadiazine 1%cream

Drug

Silver sulfadiazine applied 3 times daily until complete repithelization

Alovera gel

Other

Alovera gel applied 3 times daily until complete repithelization

Primary outcomes

  1. Degree of repithelization

    Time frame: 14 days

    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

Secondary outcomes

  1. Pain relief

    Time frame: 14 days

    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.

  2. Wound Infection

    Time frame: 14 days

    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

  3. Cost effectiveness

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.