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A randomized controlled clinical trial of a spray film-forming dressing for superficial partial-thickness burns

A prospective randomized controlled clinical trial on the safety and effectiveness of a spray film-forming dressing in clinical application

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126151
Enrollment
Unknown
Registered
2026-06-04
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial partial-thickness burn wounds

Interventions

Experimental arm:Spray film-forming dressing: During the randomized intervention period from Day0 to Day2 after injury, after routine wound care, the target wound will be covered with an A/B dual-comp
if the film is intact, it will be removed en bloc, and if incomplete, residual material will be mechanically removed before re-spraying. After the planned assessment before dressing change on Day3, th
Control arm:Conventional treatment: During the randomized intervention period from Day0 to Day2 after injury, conventional treatment with petrolatum gauze plus silver sulfadiazine will be used. After

Sponsors

The Fourth Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Male or female, aged 18–65 years. 2.Clinically diagnosed burn/scald patients with a superficial partial-thickness burn wound, enrolled within 12 hours after injury. 3.Each participant contributes only one target wound. 4.The target wound is superficial partial-thickness, with an area of 25–50 cm², and can be dressed and timed independently. 5.Before enrollment, the target wound must not have received any topical medication, disinfectant, or dressing; simple rinsing with clean water or normal saline is allowed. 6.Wound contamination is allowed, but there must be no definite infection. 7.The participant is compliant and willing to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Known allergy to hyaluronic acid or any component of the investigational product. 2.Pregnancy or lactation. 3.Severe hepatic or renal dysfunction or or insufficiency of vital organs 4.major conditions that may affect wound healing, including diabetes mellitus, vascular disease, coagulation disorders, or immune disorders. 5.The target wound has definite infection or is highly suspected of infection. 6.The target wound is deep partial-thickness or full-thickness, or is considered likely to require skin grafting or other surgical treatment. 7.The wound is located at a special site that precludes standardized treatment and timing. 8.The investigator considers the participant unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Mean bedside elapsed time for a single dressing change during Day0–Day2 after injury;

Secondary

MeasureTime frame
Mean hands-on time for a single dressing change during Day0–Day2 after injury;Time to clinical wound healing;Wound deepening on Day3;Wound infection on Day3;Dressing-change-related pain assessed by VAS;Healing rate on Day14;

Countries

China

Contacts

Public ContactChuanan Shen

The Fourth Medical Center, Chinese PLA General Hospital

shenchuanan@301hospital.com.cn+86 139 1059 5595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026