An interventional study of Silver Sulfadiazine Cream 1% and Amoxicillin and clavulanate in Burn, sponsored by abdul mateen. Not yet recruiting at 1 site in Pakistan. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by abdul mateen · Not applicable, Interventional, and Prevention
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.
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.
730 studies on the registry are indexed under Burns; 146 are open to participants now.
This study's planned enrollment of 222 is above the median of 40 across 534 interventional studies indexed under Burns.
Browse Burns studies →This is the only study on the registry with abdul mateen as lead sponsor.
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Exclusion Criteria:
Participants will receive topical antibiotic therapy alone for the management/prevention of burn wound infection according to the study protocol
Drug: Silver Sulfadiazine Cream 1%
Participants will receive topical antibiotic therapy in combination with systemic prophylactic antibiotics according to the study protocol
Drug: Silver Sulfadiazine Cream 1% · Drug: Amoxicillin and clavulanate
Silver sulfadiazine 1% cream applied once daily to the burn wound according to the departmental protocol
Drug pages: Amoxicillin · Clavulanic Acid
Amoxicillin plus clavulanate at a total dose of 50 mg/kg/day, administered three times daily according to the departmental protocol.
Incidence of burn wound infection
Occurrence of burn wound infection in pediatric burn patients, assessed clinically according to the predefined study criteria.
Time frame: From initiation of treatment through the 14-day follow-up visit
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 188 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 6 months is below that.
Counting every sponsor, half of 204 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amoxicillin · Clavulanic Acid