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Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery

RecruitingNAAges 18 Years - anyAllUppsala University Hospital
NCT07620184 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study The purpose of this study is to find out if it is safe to perform surgery on the parotid gland (the large salivary gland in front of the ear) without using a wound drain. A wound drain is a small plastic tube used to remove excess fluid from the surgical site after the operation. Currently, using a drain is the standard practice in Sweden, which often means patients must stay in hospital overnight. Researchers want to see if skipping the drain is just as safe and if it could allow more patients to return home on the same day as their surgery. What happens during the study Participants in this study will be randomly assigned to one of two groups during their surgery: Group 1: Will receive the standard treatment with a wound drain. Group 2: Will have the surgery performed without a wound drain. Apart from the use of a drain, all participants will receive the

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📋 Eligibility rules (as published)
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.
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What it tests

  • Active wound drainage (Standard of Care)
  • Omission of active wound drain
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Where

3 sites
Karolinska university hospital
Stockholm, Sweden
NÄL
Trollhättan, Sweden
Uppsala University Hospital, Department of Otorhinolaryngology
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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