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Efficacy and safety study of Pseudomonas Aeruginosa Injection in the treatment of seroma after breast cancer surgery: a randomized clinical trial

Efficacy and safety study of Pseudomonas Aeruginosa Injection in the treatment of seroma after breast cancer surgery: a multicenter, prospective, randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028198
Enrollment
Unknown
Registered
2019-12-15
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

breast cancer

Interventions

Experimental group:Place a indwelling needle in the seroma cavity and connect with a negative pressure drainage device. According to the size of the seroma and the amount of the fluid, 1 ml or 2 ml Ps
Control group:Place a indwelling needle in the seroma cavity and connect with a negative pressure drainage device. According to the size of the seroma and the amount of the fluid, 1 ml or 2 ml normal

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Willing to participate in the test and sign the written informed consent; 2. Female patients with primary breast cancer have no severe cardiac ,lung, brain and other basic diseases, and no distant metastasis; 3. Mastectomy was performed, and seroma occurred after drainage tube was removed.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent breast reconstruction immediately after operation; 2. Patients with previous history of breast surgery; 3. Patients with serious uncontrolled internal disease or acute infection; 4. Pregnant or lactating women; 5. Those who are known to be allergic to a variety of drugs; 6. Other situations that the researchers think are not suitable for selection.

Design outcomes

Primary

MeasureTime frame
drainage time;daily drainage volume;recurrence rate;

Secondary

MeasureTime frame
quality of life;range of motion of shoulder;arm circumference;pain;times of dressing change;treatment cost;

Countries

China

Contacts

Public ContactLi Ka

West China Hospital, Sichuan University

likalika127127@163.com+86 18980601488

Outcome results

None listed

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