Nishtar Medical University & Hospital, Multan
Multan, Punjab Province, 60000, Pakistan
NCT Number: NCT07367087
Partial-thickness burns are commonly treated with topical silver sulfadiazine; however, its use may delay epithelialization due to cytotoxic effects on regenerating cells. Hyaluronic acid has biological properties that may enhance wound healing when combined with silver sulfadiazine. This study aims to compare the time to re-epithelialization between silver sulfadiazine combined with hyaluronic acid and silver sulfadiazine alone in patients with bilateral partial-thickness burns using an intra-patient randomized controlled design.
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Interventional
Not applicable
Multan, Punjab Province, 60000, Pakistan
This is a prospective, intra-patient randomized controlled clinical trial conducted at a tertiary care burn center. Patients of all ages presenting with bilateral, symmetrical partial-thickness thermal burns will be enrolled, provided the burn areas are clinically comparable and suitable for intra-patient randomized treatment.
In each patient, one burn area will be randomly assigned to receive topical silver sulfadiazine combined with hyaluronic acid, while the contralateral burn area will receive silver sulfadiazine alone.
Randomization will be performed at the wound level so that each participant serves as their own control, minimizing inter-individual variability. Both interventions will be applied using identical dressing techniques and schedules. The primary outcome measure is time to re-epithelialization, defined as the number of days from initiation of treatment to achievement of complete epithelial coverage of the wound surface.
Participants will be monitored daily until epithelialization is complete. This study is designed to evaluate whether the addition of hyaluronic acid to standard silver sulfadiazine therapy accelerates wound healing in partial-thickness burns under routine clinical conditions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with acute bilateral partial-thickness (second-degree) thermal burns where both sides/areas are comparable and suitable for intra-patient treatment (one area treated with SSD+HA and the contralateral area with SSD alone)
Presentation within 72 hours of burn injury
Small to moderate total burn surface area suitable for conservative topical management
Burn wounds not requiring immediate excision or grafting at baseline
Ability to comply with daily dressing application and follow-up until complete re-epithelialization
Written informed consent from patient; for minors, parent/guardian consent and assent where applicable
Exclusion criteria
Full-thickness (third-degree) burns or mixed-depth burns in the study areas
Chemical, electrical, radiation, or inhalational burns requiring ICU or ventilatory support
Infected burn wounds at baseline requiring systemic antibiotics
Major comorbidities likely to impair wound healing (e.g., uncontrolled diabetes, severe peripheral vascular disease, immunosuppression, severe malnutrition)
Known hypersensitivity to silver sulfadiazine, sulfonamides, hyaluronic acid, or formulation components
Pregnancy or lactation (as per institutional policy)
Non-comparable bilateral burn wounds
Concurrent participation in another interventional wound or burn study
Topical application of silver sulfadiazine combined with hyaluronic acid applied once daily until complete re-epithelialization.
Topical application of silver sulfadiazine applied once daily until complete re-epithelialization.
Time frame: Up to 21 days
Time (in days) from initiation of topical treatment to complete re-epithelialization of the partial-thickness burn wound, defined as full epithelial cover without exudate.
Contact information is provided by the study sponsor or research team.
Dr Muhammad Naveed Shahzad
Other
A Prospective Intra-Patient Randomized Controlled Trial Comparing Silver Sulfadiazine Combined With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Bilateral Partial-Thickness Burns
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