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

NCT06820736 | Recruiting FDA Device

• 1 other identifier: 2199368-6
• Study Type: interventional
• Target: 975
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complications, Postoperative

Keywords

Lumbar spine surgery; drain; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Reoperation

  Relative risk of return to the operating room

  90 days postoperatively

Secondary Outcomes (5)

• Time to drain removal

  90 days postoperatively

• Drain volume

  90 days postoperatively

• Transfusion

  90 days postoperatively

• Length of Stay

  90 days postoperatively

• Complications

  90 days postoperatively

Study Arms (3)

Active Drain

EXPERIMENTAL

The drain will be used with compression suction.

Device: Drain

Passive Drain

EXPERIMENTAL

The drain will be used with gravity alone.

Device: Drain

No Drain

NO INTERVENTION

No drain will be used.

Interventions

Drain DEVICE

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

Active Drain; Passive Drain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Twin Cities Spine Center: lead
• Allina Health System: collaborator

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55404, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 35464540 BACKGROUND

• 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.

  PMID: 29680443 BACKGROUND

• 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.

  PMID: 28190206 BACKGROUND

• 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.

  PMID: 27365478 BACKGROUND

• 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.

  PMID: 26801088 BACKGROUND

• 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.

  PMID: 26944885 BACKGROUND

• 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.

  PMID: 16770213 BACKGROUND

• 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.

  PMID: 22120372 BACKGROUND

• 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.

  PMID: 20091386 BACKGROUND

• 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.

  PMID: 15668633 BACKGROUND

• 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.

  PMID: 15131430 BACKGROUND

• 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.

  PMID: 8938608 BACKGROUND

• 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.

  PMID: 34342631 BACKGROUND

• Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013 Winter;6(1):14-7.

  PMID: 24834239 BACKGROUND

• 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.

  PMID: 31934522 BACKGROUND

• 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.

  PMID: 11429335 BACKGROUND

• 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.

  PMID: 22120318 BACKGROUND

• 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.

  PMID: 34923504 BACKGROUND

• 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.

  PMID: 36260132 BACKGROUND

• 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.

  PMID: 18165756 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Drainage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Ben Mueller, MD, PhD

  Twin Cities Spine Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Dawson, PhD

CONTACT

612-775-6200; RSRCH1@tcspine.com

Berit A Swanberg

CONTACT

612-775-6200; RSRCH1@tcspine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): January 9, 2035
• Study Completion (Estimated): January 9, 2040
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)