BurnNCT07870239
Comparison of Topical Antibiotics Versus Systemic Antibiotics in Preventing Burn Wound Infection in Pediatric Burn Patients
A study testing Silver Sulfadiazine Cream 1% and Amoxicillin and clavulanate in people with Burn, run by abdul mateen at 1 site in Pakistan.
Trial summary
Burn wound infection is a common complication in children with burns and can delay healing and increase the risk of complications. This randomized controlled trial will compare two antibiotic strategies for preventing infection in pediatric burn patients. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Burn
- What is being tested?
- Silver Sulfadiazine Cream 1% and Amoxicillin and clavulanate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2026to 5 May 2027
- Phase
- Interventional
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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-13 years
- Superficial partial-thickness or deep partial-thickness scald and flame burns
- Total body surface area (TBSA) burned of 10-20%
Who cannot join
- Full-thickness burns
- Inhalational, electrical, or chemical burns
- Pre-existing comorbidities
- Traumatic injuries in addition to burns
- Burns more than 3 days old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
King Edward Medical University
Lahore, Punjab Province, 54000
Abdul Mateen, Speciality Registrar, 0092 3127074094, a.mateen345@gmail.com
About this study
Burn wound infection is a common complication in children with burns and can delay healing and increase the risk of complications. This randomized controlled trial will compare two antibiotic strategies for preventing infection in pediatric burn patients. One group will receive topical antibiotics alone, while the other group will receive topical antibiotics along with systemic antibiotics. The study will compare the occurrence of burn wound infection between the two groups to determine whether adding systemic antibiotics provides additional benefit in preventing infection.
Read the detailed description
Burn wound infection is an important complication in pediatric burn patients and may adversely affect wound healing and clinical outcomes. Topical antimicrobial agents are commonly used in the management of burn wounds; however, the routine use of systemic prophylactic antibiotics remains controversial because of concerns regarding antimicrobial resistance, adverse drug reactions, and unnecessary antibiotic exposure.
This randomized controlled trial will evaluate whether the addition of systemic prophylactic antibiotics to topical antibiotic therapy reduces the occurrence of burn wound infection in pediatric burn patients compared with topical antibiotic therapy alone.
Eligible pediatric burn patients will be randomly assigned to one of two parallel treatment groups. Participants in the first group will receive topical antibiotics alone, while participants in the second group will receive topical antibiotics in combination with systemic prophylactic antibiotics. Participants will be monitored clinically for the development of burn wound infection according to the study's predefined criteria.
The primary objective of the study is to compare the incidence of burn wound infection between the two treatment groups. The study will also assess relevant secondary clinical outcomes and adverse events associated with the antibiotic strategies.
The findings of this study may help inform the use of systemic prophylactic antibiotics in pediatric burn patients and contribute to evidence-based antibiotic stewardship in the management of pediatric burn wounds.
- Conditions
- Burn
- Being tested
- Silver Sulfadiazine Cream 1%, Amoxicillin and clavulanate
- Keywords
- Pediatric burns, Burn wound infection, Topical antibiotics, Systemic antibiotic prophylaxis, Silver sulfadiazine, Randomized controlled trial
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Sulfadiazine Cream 1%Drug
Silver sulfadiazine 1% cream applied once daily to the burn wound according to the departmental protocol
Amoxicillin and clavulanateDrug
Amoxicillin plus clavulanate at a total dose of 50 mg/kg/day, administered three times daily according to the departmental protocol.
| Study group | Role | What they receive |
|---|---|---|
| Topical Antibiotics Alone | Experimental | Participants will receive topical antibiotic therapy alone for the management/prevention of burn wound infection according to the study protocol Receives: Drug: Silver Sulfadiazine Cream 1% |
| Topical Antibiotics Plus Systemic Antibiotics | Experimental | Participants will receive topical antibiotic therapy in combination with systemic prophylactic antibiotics according to the study protocol Receives: Drug: Silver Sulfadiazine Cream 1%; Drug: Amoxicillin and clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of burn wound infection
Occurrence of burn wound infection in pediatric burn patients, assessed clinically according to the predefined study criteria.
Measured: From initiation of treatment through the 14-day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start5 Nov 2026 (estimated)
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- abdul mateen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, abdul mateen, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870239
- Sponsor's protocol ID
- 656/RC/KEMU
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No