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Bleomycin combined with OK-432 in the prevention of salivary fistula after parotidectomy: a multicenter, randomized, controlled clinical study

Bleomycin combined with OK-432 in the prevention of salivary fistula after parotidectomy: a multicenter, randomized, controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053363
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-26

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

Conditions

Parotid salivary fistula

Interventions

Experimental group:Low dose bleomycin (7.5 mg) combined with OK-432 local injection can expose parotid acinar wound during operation
control group:Nil

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient aged 18 to 75 years on the day of signing the informed consent form ; 2. Diagnosed as benign parotid tumor, and tumor resection and partial parotid gland resection are required; 3. The vital signs are stable, and the routine examination shows that the operation can be tolerated; 4. The patient has a good mental state, can follow the doctor's advice, and have regular follow-up visits; 5. Understand and be willing to participate in this clinical trial and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Existing underlying diseases will affect wound healing (such as autoimmune diseases); 2. Patients diagnosed with malignancy of the parotid gland, who need to undergo total parotidectomy and neck lymph node dissection at the same time, and require postoperative radiotherapy and chemotherapy; 3. The patient is a pregnant woman, a lactating woman during the screening period, or a woman who plans to become pregnant within six months after the end of the study; 4. Uncontrollable hyperglycemia (such as HbA1c > 12.0%); 5. Those with severe uncontrolled disease or acute systemic infection and those with other serious heart, lung, encephalopathy and other serious organ diseases; 6. Patients with psychiatric diseases; 7. Those who are considered inappropriate by the researchers to be included; 8. The patient participated in this study at any time in the past.

Design outcomes

Primary

MeasureTime frame
Parotid salivary fistula;Incidence of complications;

Countries

China

Contacts

Public ContactZhou Bin

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

dophenchou@163.com+86 13580345343

Outcome results

None listed

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