Superficial and Superficial Partial Thickness BurnsNCT07716605
Effectiveness of Alovera Gel vs 1% Silver Sulfadiazine in Superficial Partial Thickness Burn Patients in Pediatric Population.
A study testing Silver sulfadiazine 1%cream and Alovera gel in people with Superficial and Superficial Partial Thickness Burns, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Superficial and Superficial Partial Thickness Burns
- What is being tested?
- Silver sulfadiazine 1%cream and Alovera gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Silver sulfadiazine 1%cream, Alovera gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver sulfadiazine 1%creamDrug
Silver sulfadiazine applied 3 times daily until complete repithelization
Alovera gelOther
Alovera gel applied 3 times daily until complete repithelization
| Study group | Role | What they receive |
|---|---|---|
| Arm-1: Alovera group | Other | Alovera gel applied 3 times daily until complete repithelization Receives: Other: Alovera gel |
| Silver sulfadiazine 1% topical cream | Other | Silver sulfadiazine applied 3 times daily until complete repithelization Receives: Drug: Silver sulfadiazine 1%cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start20 Feb 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial and Superficial Partial Thickness BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups using coin toss/lottery method. One group will receive topical Aloe vera gel dressing, while the other group will receive 1% silver sulfadiazine dressing for the management of superficial and superficial partial-thickness burns. Both groups will be followed for 14 days to compare wound healing and treatment outcomes.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad farrukh ahmad, University of Child Health Sciences and Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716605
- Sponsor's protocol ID
- No/2099/UCHS-CH
- Status last verified
- May 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pediatric patient data is sensitive Requires strict ethical approval for sharing Most single-center academic RCTs in Pakistan do not share IPD publicly
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.
PubMed 23894900
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Alovera Gel vs 1% Silver Sulfadiazine in Superficial Partial Thickness Burn Patients in Pediatric Population.
- ClinicalTrials.gov ID
- NCT07716605
- Acronym / sponsor ID
- No/2099/UCHS-CH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups using coin toss/lottery method. One group will receive topical Aloe vera gel dressing, while the other group will receive 1% silver sulfadiazine dressing for the management of superficial and superficial partial-thickness burns. Both groups will be followed for 14 days to compare wound healing and treatment outcomes.
| Arm | Type | Receives |
|---|---|---|
| Arm-1: Alovera group | Other | Other: Alovera gelAlovera gel applied 3 times daily until complete repithelization |
| Silver sulfadiazine 1% topical cream | Other | Drug: Silver sulfadiazine 1%creamSilver sulfadiazine applied 3 times daily until complete repithelization |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver sulfadiazine 1%creamSilver sulfadiazine applied 3 times daily until complete repithelization | Drug | Silver sulfadiazine 1% topical cream |
| Alovera gelAlovera gel applied 3 times daily until complete repithelization | Other | Arm-1: Alovera group |
Primary outcome
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
3 secondary outcomes
Pain relief
Time frame: 14 days
Wound Infection
Time frame: 14 days
Cost effectiveness
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 23894900Shahzad 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.
- Individual participant dataSharing planned: No. Pediatric patient data is sensitive Requires strict ethical approval for sharing Most single-center academic RCTs in Pakistan do not share IPD publicly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver sulfadiazine 1%cream and Alovera gel in people with Superficial and Superficial Partial Thickness Burns, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of repithelization (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07716605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.