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The effect of Pseudomonas aeruginosa-mannose-sensitive hemagglutinin (PA-MSHA) on reducing the postoperative indwelling time of drainage tubes after mastectomy: A multicenter, prospective, double-blind, randomized controlled trial

The effect of Pseudomonas aeruginosa-mannose-sensitive hemagglutinin (PA-MSHA) on reducing the postoperative indwelling time of drainage tubes after mastectomy: A multicenter, prospective, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080213
Enrollment
Unknown
Registered
2024-01-23
Start date
2024-01-24
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Breast disease

Interventions

Intervention Group:On the 14th and 15th postoperative days, 2 ml and 1 ml of PA-MSHA were injected through the drainage tube, and then 8 ml and 9 ml of normal saline(NS) were injected to flush the tub
Control Group:On the 14th and 15th postoperative days, 2 ml and 1 ml of phosphate buffered saline(PBS) were injected through the drainage tube, and then 8 ml and 9 ml of normal saline(NS) were injec

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Those who voluntarily participate in the trial and sign the written informed consent; 2)Female patients with primary breast cancer without severe underlying diseases such as heart, lung, brain, etc., and without distant metastases such as bone, lung, and liver; 3) Those who have undergone mastectomy and have not reached the indication of removing the drainage tube for 14 days after the operation.

Exclusion criteria

Exclusion criteria: 1) Women during pregnancy or breastfeeding; 2) Patients with immediate breast reconstruction after surgery; 3) Those who have severe uncontrolled medical diseases or acute infections prior to surgery; 4) Those who develop postoperative infection in the incision area; 5) Those with multiple drug allergies; 6) Other conditions that the investigator considers inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
Cumulative indwelling time of drainage tubes;Daily Drainage Fluid Volume and Total Drainage Fluid Volume;Incidence of seroma after extubation;

Secondary

MeasureTime frame
Postoperative complications (short-term safety);Local recurrence rate, distant metastasis rate, and mortality rate within 5 years after surgery (long-term safety);Postoperative quality of life (quality of life score);Number of postoperative medication dressing changes, dressing change costs and related transportation costs (economics);

Countries

China

Contacts

Public ContactZhenggui Du

West China hospital, Sichuan University

docduzg@163.com+86 189 8060 5774

Outcome results

None listed

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