A Prospective Intra-Patient Randomized Controlled Trial Comparing Silver Sulfadiazine Combined With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Bilateral Partial-Thickness Burns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Time to Complete Re-epithelialization
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Silver Sulfadiazine Plus Hyaluronic Acid
Intra-patient burn areas treated with topical silver sulfadiazine combined with hyaluronic acid.
Intervention: Silver Sulfadiazine With Hyaluronic Acid (Drug)
Silver Sulfadiazine Alone
Intra-patient burn areas treated with topical silver sulfadiazine alone.
Intervention: Silver Sulfadiazine (Drug)
Outcomes
Primary Outcomes
Time to 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Muhammad Naveed Shahzad
Assistant Professor of Plastic Surgery
Nishtar Medical University