Complications, PostoperativeNCT06820736
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
A study testing Drain in people with Complications, Postoperative, run by Twin Cities Spine Center at 1 site in United States.
Trial summary
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complications, Postoperative
- What is being tested?
- Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 9 Jan 2040
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis
Who cannot join
- Infection, tumor, or trauma
- Prior lumbar fusion surgery
- Lumbar fusion surgery at more than 2 levels
- Anterior lumbar surgery
- Perioperative anticoagulation treatment
- Intraoperative incidental durotomy
- Intraoperative or postoperative cerebrospinal fluid leakage
- Intraoperative EBL greater than one liter
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55404
John M Dawson, PhD, 612-775-6200, RSRCH1@tcspine.com
Berit A Swanberg, 612-775-6200, RSRCH1@tcspine.com
About this study
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
Read the detailed description
The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.
- Conditions
- Complications, Postoperative
- Being tested
- Drain
- Keywords
- Lumbar spine surgery, drain, postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainDevice
A drain is a small flexible tube that is placed next to where the spine was operated upon.
| Study group | Role | What they receive |
|---|---|---|
| Active Drain | Experimental | The drain will be used with compression suction. Receives: Device: Drain |
| Passive Drain | Experimental | The drain will be used with gravity alone. Receives: Device: Drain |
| No Drain | No intervention | No drain will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Relative risk of return to the operating room
Measured: 90 days postoperatively
Secondary outcomes (5)
Time to drain removal
Time (minutes) to drain removal
Measured: 90 days postoperatively
Drain volume
Daily volume (mL) of fluid collected by the drain
Measured: 90 days postoperatively
Transfusion
Need (yes or no) for a postoperative transfusion
Measured: 90 days postoperatively
Length of Stay
Length of hospital stay
Measured: 90 days postoperatively
Complications
Occurrence (yes/no) of wound complications, wound dehiscence, superficial wound infection or deep wound inflection
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Jan 2025
- Primary completion9 Jan 2035 (estimated)
- Study completion9 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Complications, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 975 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Twin Cities Spine Center
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System
- Responsible party
- Sponsor
- Investigators
- Ben Mueller, MD, PhD, Principal investigator, Twin Cities Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820736
- Sponsor's protocol ID
- 2199368-6
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not want to share IPD
Publications
Reier L, Fowler JB, Arshad M, Siddiqi J. Drains in Spine Surgery for Degenerative Disc Diseases: A Literature Review to Determine Its Usage. Cureus. 2022 Mar 13;14(3):e23129. doi: 10.7759/cureus.23129. eCollection 2022 Mar.
PubMed 35464540Davidoff CL, Rogers JM, Simons M, Davidson AS. A systematic review and meta-analysis of wound drains in non-instrumented lumbar decompression surgery. J Clin Neurosci. 2018 Jul;53:55-61. doi: 10.1016/j.jocn.2018.04.038. Epub 2018 Apr 19.
PubMed 29680443Patel SB, Griffiths-Jones W, Jones CS, Samartzis D, Clarke AJ, Khan S, Stokes OM. The current state of the evidence for the use of drains in spinal surgery: systematic review. Eur Spine J. 2017 Nov;26(11):2729-2738. doi: 10.1007/s00586-017-4983-0. Epub 2017 Feb 11.
PubMed 28190206Zijlmans JL, Buis DR, Verbaan D, Vandertop WP. Wound drains in non-complex lumbar surgery: a systematic review. Bone Joint J. 2016 Jul;98-B(7):984-9. doi: 10.1302/0301-620X.98B7.37190.
PubMed 27365478Liu Y, Li Y, Miao J. Wound drains in posterior spinal surgery: a meta-analysis. J Orthop Surg Res. 2016 Jan 22;11:16. doi: 10.1186/s13018-016-0351-8.
PubMed 26801088Liu JM, Chen WZ, Fu BQ, Chen JW, Liu ZL, Huang SH. The Use of Closed Suction Drainage in Lumbar Spinal Surgery: Is It Really Necessary? World Neurosurg. 2016 Jun;90:109-115. doi: 10.1016/j.wneu.2016.02.091. Epub 2016 Mar 2.
PubMed 26944885Mirzai H, Eminoglu M, Orguc S. Are drains useful for lumbar disc surgery? A prospective, randomized clinical study. J Spinal Disord Tech. 2006 May;19(3):171-7. doi: 10.1097/01.bsd.0000190560.20872.a7.
PubMed 16770213Walid MS, Abbara M, Tolaymat A, Davis JR, Waits KD, Robinson JS 3rd, Robinson JS Jr. The role of drains in lumbar spine fusion. World Neurosurg. 2012 Mar-Apr;77(3-4):564-8. doi: 10.1016/j.wneu.2011.05.058. Epub 2011 Nov 7.
PubMed 22120372Scuderi GJ, Brusovanik GV, Fitzhenry LN, Vaccaro AR. Is wound drainage necessary after lumbar spinal fusion surgery? Med Sci Monit. 2005 Feb;11(2):CR64-6.
PubMed 15668633Brown MD, Brookfield KF. A randomized study of closed wound suction drainage for extensive lumbar spine surgery. Spine (Phila Pa 1976). 2004 May 15;29(10):1066-8. doi: 10.1097/00007632-200405150-00003.
PubMed 15131430Payne DH, Fischgrund JS, Herkowitz HN, Barry RL, Kurz LT, Montgomery DM. Efficacy of closed wound suction drainage after single-level lumbar laminectomy. J Spinal Disord. 1996 Oct;9(5):401-3.
PubMed 8938608Smith VA, Coffman CJ, Hudgens MG. Interpreting the Results of Intention-to-Treat, Per-Protocol, and As-Treated Analyses of Clinical Trials. JAMA. 2021 Aug 3;326(5):433-434. doi: 10.1001/jama.2021.2825. No abstract available.
PubMed 34342631Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013 Winter;6(1):14-7.
PubMed 24834239Porto GBF, Jeffrey Wessell DO, Alvarado A, Arnold PM, Buchholz AL. Anticoagulation and Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):53S-64S. doi: 10.1177/2192568219852051. Epub 2020 Jan 6.
PubMed 31934522Horlocker TT, Nuttall GA, Dekutoski MB, Bryant SC. The accuracy of coagulation tests during spinal fusion and instrumentation. Anesth Analg. 2001 Jul;93(1):33-8. doi: 10.1097/00000539-200107000-00008.
PubMed 11429335
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
- ClinicalTrials.gov ID
- NCT06820736
- Acronym / sponsor ID
- 2199368-6
- Conditions
- Complications, Postoperative
- Keywords
- Lumbar spine surgery, drain, postoperative complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 975 participants (estimated)
- Lead sponsor
- Twin Cities Spine CenterUniversity, hospital or other
- Collaborators
- Allina Health System
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 9 Jan 2035 (estimated)
- Study completion
- 9 Jan 2040 (estimated)
- First posted
- 11 Feb 2025 (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.
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
Detailed description
The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Drain | Experimental | Device: DrainThe drain will be used with compression suction. |
| Passive Drain | Experimental | Device: DrainThe drain will be used with gravity alone. |
| No Drain | No intervention | –No drain will be used. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis
Key exclusion criteria (8 listed)
- Infection, tumor, or trauma
- Prior lumbar fusion surgery
- Lumbar fusion surgery at more than 2 levels
- Anterior lumbar surgery
- Perioperative anticoagulation treatment
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 |
|---|---|---|
| DrainA drain is a small flexible tube that is placed next to where the spine was operated upon. | Device | Active Drain, Passive Drain |
Primary outcome
Reoperation
Time frame: 90 days postoperatively
Relative risk of return to the operating room
5 secondary outcomes
Time to drain removal
Time frame: 90 days postoperatively
Drain volume
Time frame: 90 days postoperatively
Transfusion
Time frame: 90 days postoperatively
Length of Stay
Time frame: 90 days postoperatively
Complications
Time frame: 90 days 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 2 Jul 2026.
- Background: PubMed 35464540Reier L, Fowler JB, Arshad M, Siddiqi J. Drains in Spine Surgery for Degenerative Disc Diseases: A Literature Review to Determine Its Usage. Cureus. 2022 Mar 13;14(3):e23129. doi: 10.7759/cureus.23129. eCollection 2022 Mar.
- Background: PubMed 29680443Davidoff CL, Rogers JM, Simons M, Davidson AS. A systematic review and meta-analysis of wound drains in non-instrumented lumbar decompression surgery. J Clin Neurosci. 2018 Jul;53:55-61. doi: 10.1016/j.jocn.2018.04.038. Epub 2018 Apr 19.
- Background: PubMed 28190206Patel SB, Griffiths-Jones W, Jones CS, Samartzis D, Clarke AJ, Khan S, Stokes OM. The current state of the evidence for the use of drains in spinal surgery: systematic review. Eur Spine J. 2017 Nov;26(11):2729-2738. doi: 10.1007/s00586-017-4983-0. Epub 2017 Feb 11.
- Background: PubMed 27365478Zijlmans JL, Buis DR, Verbaan D, Vandertop WP. Wound drains in non-complex lumbar surgery: a systematic review. Bone Joint J. 2016 Jul;98-B(7):984-9. doi: 10.1302/0301-620X.98B7.37190.
- Background: PubMed 26801088Liu Y, Li Y, Miao J. Wound drains in posterior spinal surgery: a meta-analysis. J Orthop Surg Res. 2016 Jan 22;11:16. doi: 10.1186/s13018-016-0351-8.
- Background: PubMed 26944885Liu JM, Chen WZ, Fu BQ, Chen JW, Liu ZL, Huang SH. The Use of Closed Suction Drainage in Lumbar Spinal Surgery: Is It Really Necessary? World Neurosurg. 2016 Jun;90:109-115. doi: 10.1016/j.wneu.2016.02.091. Epub 2016 Mar 2.
- Background: PubMed 16770213Mirzai H, Eminoglu M, Orguc S. Are drains useful for lumbar disc surgery? A prospective, randomized clinical study. J Spinal Disord Tech. 2006 May;19(3):171-7. doi: 10.1097/01.bsd.0000190560.20872.a7.
- Background: PubMed 22120372Walid MS, Abbara M, Tolaymat A, Davis JR, Waits KD, Robinson JS 3rd, Robinson JS Jr. The role of drains in lumbar spine fusion. World Neurosurg. 2012 Mar-Apr;77(3-4):564-8. doi: 10.1016/j.wneu.2011.05.058. Epub 2011 Nov 7.
- Background: PubMed 15668633Scuderi GJ, Brusovanik GV, Fitzhenry LN, Vaccaro AR. Is wound drainage necessary after lumbar spinal fusion surgery? Med Sci Monit. 2005 Feb;11(2):CR64-6.
- Background: PubMed 15131430Brown MD, Brookfield KF. A randomized study of closed wound suction drainage for extensive lumbar spine surgery. Spine (Phila Pa 1976). 2004 May 15;29(10):1066-8. doi: 10.1097/00007632-200405150-00003.
- Background: PubMed 8938608Payne DH, Fischgrund JS, Herkowitz HN, Barry RL, Kurz LT, Montgomery DM. Efficacy of closed wound suction drainage after single-level lumbar laminectomy. J Spinal Disord. 1996 Oct;9(5):401-3.
- Background: PubMed 34342631Smith VA, Coffman CJ, Hudgens MG. Interpreting the Results of Intention-to-Treat, Per-Protocol, and As-Treated Analyses of Clinical Trials. JAMA. 2021 Aug 3;326(5):433-434. doi: 10.1001/jama.2021.2825. No abstract available.
- Individual participant dataSharing planned: No. We do not want to share IPD
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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.
Ben Mueller, MD, PhD principal investigator
Twin Cities Spine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain in people with Complications, Postoperative, run by Twin Cities Spine Center at 1 site in United States.
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 1 inclusion and 8 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 John M Dawson, PhD (612-775-6200, RSRCH1@tcspine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (time frame: 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820736, which also lists 20 linked publications.
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 2 Jul 2026.