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Not yet recruiting NCT07367087

Silver Sulfadiazine With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Partial-Thickness Burns

No phase Interventional Partial-Thickness Burn, Thermal Burn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silver Sulfadiazine With Hyaluronic Acid, Silver Sulfadiazine.
Who it may be relevant to
Registry conditions: Partial-Thickness Burn, Thermal Burn. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Intra-Patient Randomized Controlled Trial Comparing Silver Sulfadiazine Combined With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Bilateral Partial-Thickness Burns

Overview

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.

Interventions

  • Drug Silver Sulfadiazine With Hyaluronic Acid
    Topical application of silver sulfadiazine combined with hyaluronic acid applied once daily until complete re-epithelialization.
  • Drug Silver Sulfadiazine
    Topical application of silver sulfadiazine applied once daily until complete re-epithelialization.

Primary outcome measures

  • Time to Complete Re-epithelialization [Time frame: Up to 21 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Nishtar Medical University & Hospital, Multan — Multan

Identifiers

NCT: NCT07367087 · SSDHA-PTB-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗