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A randomized, blind, multicenter clinical study on NeutroPhase in Treatment of deep second degree burn with wound infection

A randomized, blind, Prontosan parallel control, multicenter clinical study to evaluate the efficacy and safety of NeutroPhase in Treatment of deep second degree burn with wound infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-15007580
Enrollment
Unknown
Registered
2015-12-01
Start date
2015-12-22
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

deep second degree burn with wound infection

Interventions

treatment group:NeutroPhase
control group:Prontosan

Sponsors

Changhai hospital, Second Military Medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 to 60 years, Male or female; (2) The clinical diagnosis of deep second degree burn, has been less than 7 days early treatment, the wound was red, swollen, hot, painful or purulent secretion or bacterial positive; (3) The total area of the wound was <10%TBSA (in the palm of the hand), and the wound was between 5cm*5cm~10cm*10cm, wound position for the limbs or trunk; (4) The investigator confirmed that the wounds need to be treated with dressing change; (5) Agreed to participate in the study and signed a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Chemical burn, electric burn, diabetes, and other chronic wounds; (2) Severe malnutrition, albumin 38.5 degree C or WBC>12*10^9/L cell or wound swelling edge>5cm; (4) Subjects were treated with antimicrobial agents for the severe systemic infections; (5) Cancer, radiotherapy or chemotherapy; (6) Combined with severe primary diseases such as cardiovascular, liver, kidney and blood system, or psychotic; (7) Has been known to have a history of allergy to the ingredients of this product and the control, or other chemical structures similar, or allergic constitution (2 and above) of the allergen; (8) Pregnant or lactating women and family planners; (9) The subjects participated in other clinical studies in 1 months before enrolling; (10) The investigator considered that subjects had other conditions that were not suitable for the clinical study.

Design outcomes

Primary

MeasureTime frame
The clinical efficiency of the treatment of the end visit.;The bacterial clearance rate at the end of treatment (clearance rate + assuming removal rate);

Secondary

MeasureTime frame
Bacterial clearance rate of all kinds of pathogenic bacteria in the treatment of fourth days, the end of the treatment.;Target wound healing rate at the end of the treatment;

Countries

China

Contacts

Public ContactZhu Shihui
doctorzhushihui@163.com+86 021-31161826

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026