NCT07367087

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Complete Re-epithelialization

    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

Study Arms (2)

Silver Sulfadiazine Plus Hyaluronic Acid

EXPERIMENTAL

Intra-patient burn areas treated with topical silver sulfadiazine combined with hyaluronic acid.

Drug: Silver Sulfadiazine With Hyaluronic Acid

Silver Sulfadiazine Alone

ACTIVE COMPARATOR

Intra-patient burn areas treated with topical silver sulfadiazine alone.

Drug: Silver Sulfadiazine

Interventions

Topical application of silver sulfadiazine applied once daily until complete re-epithelialization.

Silver Sulfadiazine Alone

Topical application of silver sulfadiazine combined with hyaluronic acid applied once daily until complete re-epithelialization.

Silver Sulfadiazine Plus Hyaluronic Acid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Medical University & Hospital, Multan

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Interventions

Silver SulfadiazineHyaluronic Acid

Intervention Hierarchy (Ancestors)

SulfadiazineBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Muhammad N Shahzad, MBBS, MCPS,FCPS,FCPS

    Department of Plastic Surgery, Nishtar Medical University / Nishtar Hospital Multan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad N Shahzad, MBBS, MCPS,FCPS,FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Intra-patient randomized controlled design in which each participant receives both interventions applied to bilateral burn wounds.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Plastic Surgery

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations