Parotid NeoplasmsSNaPsNCT07620184
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
A study testing Omission of active wound drain in people with Parotid Neoplasms and Post-operative Complications, run by Uppsala University Hospital at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Neoplasms, Post-operative Complications, Seroma as Procedural Complication
- What is being tested?
- Omission of active wound drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesSweden
- Study dates
- 6 May 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Karolinska university hospital
Stockholm
- Recruiting
NÄL
Trollhättan
- Recruiting
Uppsala University Hospital, Department of Otorhinolaryngology
Uppsala
Karl Sandström, MD, PhD, +46 76 113 29 52, karl.sandstrom@akademiska.se
About this study
Official title: A Prospective, Randomized, Multicenter Non-Inferiority Trial Evaluating the Safety of Parotidectomy Without Active Surgical Drainage (Svenska Nationella Parotisstudien)
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
Read more
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.
- Being tested
- Active wound drainage (Standard of Care), Omission of active wound drain
- Keywords
- Parotidectomy, Surgical drainage, Wound drains, Postoperative complications, Seroma, Hematoma, Randomised controlled trial, Non-inferiority, Salivary gland surgery, Quality of life
- Medical subject headings
- Parotid Neoplasms, Postoperative Complications, Seroma, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active wound drainage (Standard of Care)Procedure or surgery
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 drainProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Drainless Group (Intervention) | Experimental | Participants in this group will undergo partial or superficial parotidectomy without the placement of a postoperative active wound drain. The surgical site is closed according to the standard technique, but the suction drain is omitted. Receives: Procedure: Omission of active wound drain |
| Standard Drain Group (Control) | Active comparator | Participants in this group will undergo partial or superficial parotidectomy with the placement of a postoperative active wound drain, according to current standard clinical routine in Sweden. Receives: Procedure: Active wound drainage (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of early postoperative complications requiring intervention
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).
Measured: From the day of surgery up to 7 weeks postoperatively.
Secondary outcomes (6)
Requirement for inpatient hospital care after the day of surgery.
Evaluation of the number of participants requiring unplanned hospital admission or prolonged stay related to the surgical procedure.
Measured: From the first postoperative day up to 6 months
Postoperative facial nerve function.
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).
Measured: Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
Incidence of Frey's syndrome
Subjective and objective assessment of gustatory sweating (Frey's syndrome).
Measured: 6 months postoperatively.
Health-related quality of life (EQ-5D-5L)
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.
Measured: 7 weeks, and 6 months postoperatively
Postoperative length of stay
Total number of days spent in hospital following the surgical procedure.
Measured: Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
Symptom-specific outcomes (SwPOI-8)
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.
Measured: 7 weeks and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start6 May 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Västra Götalandsregionen, Göteborg University
- Responsible party
- Principal investigator, Karl Sandström, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620184
- Sponsor's protocol ID
- 2025-07555-01
- Other IDs
- 2025
- Acronym
- SNaPs
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to current Swedish legislation and the European General Data Protection Regulation (GDPR), which protect the privacy of study participants. Sharing of pseudonymised individual-level data would require specific legal review and institutional agreements to ensure continued data protection
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Non-Inferiority Trial Evaluating the Safety of Parotidectomy Without Active Surgical Drainage (Svenska Nationella Parotisstudien)
- ClinicalTrials.gov ID
- NCT07620184
- Acronym / sponsor ID
- SNaPs / 2025-07555-01
- Keywords
- Parotidectomy, Surgical drainage, Wound drains, Postoperative complications, Seroma, Hematoma, Randomised controlled trial, Non-inferiority
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University, Västra Götalandsregionen, Göteborg University
- Study start
- 6 May 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drainless Group (Intervention) | Experimental | Procedure: Omission of active wound drainParticipants in this group will undergo partial or superficial parotidectomy without the placement of a postoperative active wound drain. The surgical site is closed according to the standard technique, but the suction drain is omitted. |
| Standard Drain Group (Control) | Active comparator | Procedure: Active wound drainage (Standard of Care)Participants in this group will undergo partial or superficial parotidectomy with the placement of a postoperative active wound drain, according to current standard clinical routine in Sweden. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active wound drainage (Standard of Care)An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden. | Procedure or surgery | Standard Drain Group (Control) |
| Omission of active wound drainThe 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. | Procedure or surgery | Drainless Group (Intervention) |
Primary outcome
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).
6 secondary outcomes
Requirement for inpatient hospital care after the day of surgery.
Time frame: From the first postoperative day up to 6 months
Postoperative facial nerve function.
Time frame: Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
Incidence of Frey's syndrome
Time frame: 6 months postoperatively.
Health-related quality of life (EQ-5D-5L)
Time frame: 7 weeks, and 6 months postoperatively
Postoperative length of stay
Time frame: Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
Symptom-specific outcomes (SwPOI-8)
Time frame: 7 weeks and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to current Swedish legislation and the European General Data Protection Regulation (GDPR), which protect the privacy of study participants. Sharing of pseudonymised individual-level data would require specific legal review and institutional agreements to ensure continued data protection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of active wound drain in people with Parotid Neoplasms and Post-operative Complications, run by Uppsala University Hospital at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl Sandström, MD, PhD (+46 76 113 29 52, karl.sandstrom@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of early postoperative complications requiring intervention (time frame: From the day of surgery up to 7 weeks postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.