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NCT Number: NCT07620184

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

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 same surgical care. After the operation, researchers will monitor the healing process. Participants will be asked to fill out questionnaires about their health and any symptoms at one week and six months after their surgery.

The goal of the study The main goal is to compare the safety of the two methods. Researchers will look at whether there is any difference in the number of complications, such as fluid build-up (seroma), bleeding, or infections, between those who had a drain and those who did not. The study also aims to evaluate if avoiding a drain improves the patient's quality of life and if it is a more cost-effective approach for the healthcare system.

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Key information

Conditions

Parotid Neoplasms Head and Neck Neoplasms Hematoma Hemorrhage Inflammation Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Parotid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Complications Postoperative Complications Salivary Gland Diseases Salivary Gland Neoplasms Seroma Seroma as Procedural Complication Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska university hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active wound drainage (Standard of Care)

Procedure

An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden.

Omission of active wound drain

Procedure

The surgical procedure is performed without the insertion of an active suction drain. All other aspects of the surgical care and postoperative monitoring follow standard protocols.

Primary outcomes

  1. Cumulative incidence of early postoperative complications requiring intervention

    Time frame: From the day of surgery up to 7 weeks postoperatively.

    The primary outcome is the number of participants experiencing at least one early complication, defined as a salivary fistula, haematoma, seroma/sialocele, or surgical site infection that requires invasive or medical treatment (e.g., aspiration, re-operation, or antibiotics).

Secondary outcomes

  1. Requirement for inpatient hospital care after the day of surgery.

    Time frame: From the first postoperative day up to 6 months

    Evaluation of the number of participants requiring unplanned hospital admission or prolonged stay related to the surgical procedure.

  2. Postoperative facial nerve function.

    Time frame: Baseline (preoperative), at discharge, at 7 weeks, and at 6 months

    Assessment of facial nerve function using the Sunnybrook Facial Grading System (SFGS). The SFGS is a clinical evaluation scale that ranges from 0 to 100. A score of 0 indicates complete facial paralysis, while a score of 100 represents normal facial function. Higher scores indicate a better outcome (better facial nerve function).

  3. Incidence of Frey's syndrome

    Time frame: 6 months postoperatively.

    Subjective and objective assessment of gustatory sweating (Frey's syndrome).

  4. Health-related quality of life (EQ-5D-5L)

    Time frame: 7 weeks, and 6 months postoperatively

    Evaluated using the EQ-5D-5L descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension is scored from 1 (no problems) to 5 (extreme problems). The digits are combined into a 5-digit health state profile, which is then converted into a single index value. Index values range from less than 0 (where 0 is a state equivalent to death and negative values are states worse than death) to 1.0 (perfect health). Higher scores indicate a better quality of life outcome.

  5. Postoperative length of stay

    Time frame: Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.

    Total number of days spent in hospital following the surgical procedure.

  6. Symptom-specific outcomes (SwPOI-8)

    Time frame: 7 weeks and 6 months postoperatively

    Measured using the Swedish Parotidectomy Outcome Inventory 8 (SwPOI-8), a disease-specific instrument assessing subjective symptoms after parotid surgery (e.g., pain, sensory disturbances, scarring, facial palsy, sweating, dry mouth). Each of the 8 items is scored on a Likert scale from 0 to 3, with a total score ranging from 0 to 24. Higher scores indicate a greater symptom burden and a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Karl Sandström, MD, PhD

CONTACT

[email protected]

+46 76 113 29 52

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Göteborg University
  • Uppsala University
  • Västra Götalandsregionen

Registry information

Official study title

A Prospective, Randomized, Multicenter Non-Inferiority Trial Evaluating the Safety of Parotidectomy Without Active Surgical Drainage (Svenska Nationella Parotisstudien)

Acronym: SNaPs

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Jun 2, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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