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Intraoperative Botulinum Toxin Injection in Parotidectomy

The effect of intraoperative botulinum toxin injection in parotidectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004450
Enrollment
60
Registered
2019-11-19
Start date
2017-08-07
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

None listed

Interventions

Drug : Botulinum toxin (type A) is intraoperatively administered during partial parotidectomy to prevent sialocele/salivary fistula. Botulinum toxin (5 unit/ml) was injected at the 5 points indicated.

Sponsors

Pusan National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who supposed to undergo partial parotidectomy for therapeutic purpose.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: patients who have (1) the history of botulinum toxin administration in 3 months (2) the experience of hypersensitivity or allergic reaction for botulinum toxin (3) the history of the operation for high-risk cancer (4) coagulopathies (5) the possibility of pregnancy or are breastfeeding (6) the history of spastic cerebral palsy, peripheral motor neuropathies (Amyotrophic lateral sclerosis and other motor neuron diseases) (7) the history of neuromuscular junction diseases (myasthenia gravis) and other neuromuscular diseases (8) severe respiratory failure (9) systemic lupus erythematosus (10) the needs of aminoglycoside, spectinomycin, polymyxin, tetracycline and lincomycin.

Design outcomes

Primary

MeasureTime frame
The incidence of facial nerve paralysis for safety;The incidence of postoperative sialocele and salivary fistula for the efficacy.

Secondary

MeasureTime frame
Drainage volume during admission;Minor complication after discharge (hemorrhage/hematoma, infection, wound dehiscence, re-admission, dry mouth)

Countries

Korea, Republic of

Contacts

Public ContactWonjae Cha

Pusan National University Hospital

chawonjae@gmail.com+82-51-240-7336

Outcome results

None listed

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