ClinicalTrials.gg
RecruitingNCT06820736Updated Jul 2, 2026

A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion

An interventional study of Drain in Complications, Postoperative, sponsored by Twin Cities Spine Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Twin Cities Spine Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
975
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Complications, Postoperative

Keywords

  • Lumbar spine surgery
  • drain
  • postoperative complications
03

In context

Postoperative Complications

1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.

This study's planned enrollment of 975 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Twin Cities Spine Center is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
975 participants (estimated)

Study arms

  • Experimental
    Active Drain

    The drain will be used with compression suction.

    Device: Drain

  • Experimental
    Passive Drain

    The drain will be used with gravity alone.

    Device: Drain

  • No intervention
    No Drain

    No drain will be used.

Interventions

  • DeviceDrain

    A drain is a small flexible tube that is placed next to where the spine was operated upon.

06

What researchers measure

Primary outcomes

  1. Reoperation

    Relative risk of return to the operating room

    Time frame: 90 days postoperatively

Secondary outcomes

  1. Time to drain removal

    Time (minutes) to drain removal

    Time frame: 90 days postoperatively

  2. Drain volume

    Daily volume (mL) of fluid collected by the drain

    Time frame: 90 days postoperatively

  3. Transfusion

    Need (yes or no) for a postoperative transfusion

    Time frame: 90 days postoperatively

  4. Length of Stay

    Length of hospital stay

    Time frame: 90 days postoperatively

  5. Complications

    Occurrence (yes/no) of wound complications, wound dehiscence, superficial wound infection or deep wound inflection

    Time frame: 90 days postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 35464540 ↗
  • Davidoff 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 29680443 ↗
  • Patel 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 28190206 ↗
  • Zijlmans 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 27365478 ↗
  • Liu 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 26801088 ↗
  • Liu 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 26944885 ↗
  • Mirzai 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 16770213 ↗
  • Walid 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 22120372 ↗
  • Scuderi 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 15668633 ↗
  • Brown 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 15131430 ↗
  • Payne 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 8938608 ↗
  • Smith 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 34342631 ↗
  • Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013 Winter;6(1):14-7. PubMed 24834239 ↗
  • Porto 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 31934522 ↗
  • Horlocker 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 ↗
  • Tomasino A, Lumenta CB. To drain or not to drain: about using wound drainage after instrumented spine procedures. World Neurosurg. 2012 Mar-Apr;77(3-4):466-7. doi: 10.1016/j.wneu.2011.07.035. Epub 2011 Nov 7. No abstract available. PubMed 22120318 ↗
  • Butler AJ, Donnally CJ 3rd, Goz V, Basques BA, Vaccaro AR, Schroeder GD. Symptomatic Postoperative Epidural Hematoma in the Lumbar Spine. Clin Spine Surg. 2022 Nov 1;35(9):354-362. doi: 10.1097/BSD.0000000000001278. Epub 2021 Dec 20. PubMed 34923504 ↗
  • Chen Q, Zhong X, Liu W, Wong C, He Q, Chen Y. Incidence of postoperative symptomatic spinal epidural hematoma requiring surgical evacuation: a systematic review and meta-analysis. Eur Spine J. 2022 Dec;31(12):3274-3285. doi: 10.1007/s00586-022-07421-6. Epub 2022 Oct 19. PubMed 36260132 ↗
  • Sokolowski MJ, Garvey TA, Perl J 2nd, Sokolowski MS, Cho W, Mehbod AA, Dykes DC, Transfeldt EE. Prospective study of postoperative lumbar epidural hematoma: incidence and risk factors. Spine (Phila Pa 1976). 2008 Jan 1;33(1):108-13. doi: 10.1097/BRS.0b013e31815e39af. PubMed 18165756 ↗
  • Kanayama M, Oha F, Togawa D, Shigenobu K, Hashimoto T. Is closed-suction drainage necessary for single-level lumbar decompression?: review of 560 cases. Clin Orthop Relat Res. 2010 Oct;468(10):2690-4. doi: 10.1007/s11999-010-1235-6. Epub 2010 Jan 21. PubMed 20091386 ↗

Individual participant data

Plan to share: No — We do not want to share IPD

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jan 2035, 119 months after the start.

Of 391 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 119 months is above that.

Counting every sponsor, half of 395 studies reached it within 21 months; a quarter within 8 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2025
First posted
Feb 11, 2025
StartActual
Jan 10, 2025
Primary completionEst.
Jan 9, 2035
CompletionEst.
Jan 9, 2040
Last update
Jul 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06820736
Lead sponsor
Twin Cities Spine Center
Collaborators
Allina Health System
Responsible party
Sponsor
First posted
Feb 11, 2025
Start date
Jan 10, 2025
Primary completion
Jan 9, 2035 (estimated)
Completion
Jan 9, 2040 (estimated)
Last update
Jul 2, 2026

Study contacts

John M Dawson, PhD
Contact
RSRCH1@tcspine.com
612-775-6200
Berit A Swanberg
Contact
RSRCH1@tcspine.com
612-775-6200
Ben Mueller, MD, PhD
principal investigator · Twin Cities Spine Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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