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Evaluation of platelet rich fibrin effect on length of hospital stays and complications of superficial parotidectomy

Evaluation of platelet rich fibrin effect on length of hospital stays and complications of superficial parotidectomy: A randomized double blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250802066734N1
Enrollment
25
Registered
2025-10-15
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Benign neoplasms of superficial lobe of parotid gland. Benign neoplasm of parotid gland

Interventions

Intervention 1: Intervention group: Standard superficial parotidectomy with facial nerve preservation and removal of the mass with a cuff of normal tissue will be done. At the end of the surgery, a 15

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients referred to Loghman Hakim Hospital ENT clinic with probably benign superficial parotid tumors (based on sonography, FNA, MRI or CT-scan as needed) candidates for superficial parotidectomy Signed the informed consent form and willing to participate in the study Willing to participate in follow up visits

Exclusion criteria

Exclusion criteria: Patients under 18 years old or not willing to participate in the study Positive history of collagen vascular diseases, diabetes or medications or disorders affecting tissue healing, platelets, hemostasis or cell division Positive history of previous parotid surgery Suspicious for malignant parotid tumors or needing other treatment plans Previous history of Facial nerve disorders, facial spasm or paresis, or Frey's syndrome

Design outcomes

Primary

MeasureTime frame
Length of post operation hospital stay (in days). Timepoint: Immediately after surgery, Daily visits in hospital. Method of measurement: Medical Records.;Length of Drain Requirement (Days). Timepoint: Immediately after surgery, Daily visits in hospital. Method of measurement: Medical Records.;Facial Nerve Paralysis. Timepoint: Immediate Post-op visit. Method of measurement: Physical Examination.;Sialocele formation (subcutaneous accumulation of saliva) in surgical site. Timepoint: Immediate post-op, week 1-2-3-4, then monthly 2-3-4-5-6. Method of measurement: Physical Examination and aspiration of accumulated fluid (if present).;Salivary fistula formation (saliva drainage through surgical site skin). Timepoint: Immediate post-op, week 1-2-3-4, then monthly 2-3-4-5-6. Method of measurement: Physical Examination (present or not present).;Hematoma formation (subcutaneous blood accumulation in surgical field). Timepoint: Immediate post-op, week 1-2-3-4, then monthly 2-3-4-5-6. Method of measurement: Physical Examination and aspiration of accumulated fluid (if present).;Frey's Syndrome (erythema, perspiration or swelling of surgical area after eating/ drinking). Timepoint: week 1-2-3-4 post operation, then monthly 2-3-4-5-6. Method of measurement: History and Physical Examination.

Secondary

MeasureTime frame
Time needed for complete facial nerve recovery (if weakened post operation). Timepoint: Weekly evaluation until full recovery or 6 months. Method of measurement: Physical Examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehran Nematizadeh

Shahid Beheshti University of Medical Sciences

mehran.nematizadeh@gmail.com+98 21 5102 5000

Outcome results

None listed

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