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Are drains really necessary for patients undergoing parotid surgery?

A Randomized controlled trial comparing the use of drains versus no drains in patients undergoing superficial parotidectomy - SPADE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020209
Enrollment
100
Registered
2019-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D110- Benign neoplasm of parotid gland Health Condition 2: null- superficial parotidectomy

Interventions

Intervention1: NO DRAIN: PATIENTS UNDERGOING SUPERFICIAL PAROTIDECTOMY, TO HAVE NO DRAIN PLACED INTRA OPERATIVELY Control Intervention1: DRAIN: PATIENTS UNDERGOING SUPERFICIAL PAROTIDECTOMY TO HAVE D

Sponsors

FLUID RESEARCH GRANT CMC VELLORE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing superficial parotidectomy for benign conditions of the superficial lobe. Any tumors with histopathological surprise i.e. indicating malignant pathology postoperatively shall be included in the study upto the next surgery.

Exclusion criteria

Exclusion criteria: • Patients aged • Pregnant women • Patients on anticoagulant therapy • Patients undergoing additional head and neck procedures at time of parotidectomy • Not consenting for the study • Clinical and histopathological evidence of malignancy prior to surgery • Patients undergoing total or radical parotidectomy

Design outcomes

Primary

MeasureTime frame
Clinically significant seroma formationTimepoint: immediate post operative period till suture removal

Secondary

MeasureTime frame
Facial nerve paralysisTimepoint: immediate post operative period till suture removal;Hematoma formationTimepoint: immediate post operative period till suture removal;Surgical site infectionTimepoint: immediate post operative period till suture removal

Countries

India

Contacts

Public ContactADITI MISHRA

CMC, Vellore

drrajini.j@gmail.com

Outcome results

None listed

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