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

January 16, 2026 updated by: Dr Muhammad Naveed Shahzad

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • Nishtar Medical University & Hospital, Multan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver Sulfadiazine Plus Hyaluronic Acid
Intra-patient burn areas treated with topical silver sulfadiazine combined with hyaluronic acid.
Drug: Silver Sulfadiazine With Hyaluronic Acid
Topical application of silver sulfadiazine combined with hyaluronic acid applied once daily until complete re-epithelialization.
Active Comparator: Silver Sulfadiazine Alone
Intra-patient burn areas treated with topical silver sulfadiazine alone.
Drug: Silver Sulfadiazine
Topical application of silver sulfadiazine applied once daily until complete re-epithelialization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Muhammad Naveed Shahzad

Investigators

  • Principal Investigator: Muhammad N Shahzad, MBBS, MCPS,FCPS,FCPS, Department of Plastic Surgery, Nishtar Medical University / Nishtar Hospital Multan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSDHA-PTB-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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