Parotid gland surgery without wound drains: can patients go home the same day?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing partial or superficial parotidectomy will be randomly assigned to have either a wound drain placed or no drain during surgery. All other care remains the same, and patients will be monitored after surgery to compare safety and healing. The goal is to see if omitting the drain can reduce hospital stays without increasing complications such as fluid buildup. The study is conducted at multiple Swedish centers led by Uppsala University Hospital and collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients scheduled to undergo partial or superficial parotidectomy without concurrent soft tissue surgery, in cases where a wound drain is traditionally used (extirpation of single adjacent lymph nodes is acceptable).
* ASA physical status class 1-3.
* Aged 18 years or older.
* The patient understands the participant information and is able to make an informed choice.

Exclusion Criteria:

* Previous parotid surgery on the same side
* Tumour with parapharyngeal extension.
* Ongoing or planned perioperative treatment with tranexamic acid.
* Ongoing treatment with dual antiplatelet therapy (single agent therapy, such as Aspirin or Clopidogrel, is not an exclusion criterion).
* Ongoing treatment with anticoagulants (NOAC, Warfarin) at the time of surgery. NOAC must be discontinued at least 24 hours before surgery.
* Ongoing treatment with low molecular weight heparin in doses higher than: Fragmin 5000 IU/day, Clexane 40 mg/day, or Innohep 4500 IU/day.Ongoing treatment for malignancy.Known coagulation disorder.
* Platelet count \<150 x 10⁹
* PK-INR \>1.2.
* Hb \<120 g/L.
* APTT \>42s.
* Preoperative impaired facial nerve function on the affected side (Sunnybrook Facial Grading System score \<90).
* Supplementary postoperative treatment such as radiotherapy or extended surgery.

Where it's running

• Karolinska university hospital
  Stockholm, Sweden Recruiting
• Näl
  Trollhättan, Sweden Recruiting
• Uppsala University Hospital, Department of Otorhinolaryngology
  Uppsala, Sweden Recruiting

Study contacts

• Study coordinator: Karl Sandström, MD, PhD
• Email: karl.sandstrom@akademiska.se
• Phone: +46 76 113 29 52

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.