NCT01608854

Brief Summary

In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup around the spinal cord. The purpose of this study is to determine whether postoperative antibiotic treatment continued for the duration of time a drain is in place results in a lower infection rate than antibiotics given for only 24 hours postoperatively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

2.4 years

First QC Date

May 29, 2012

Last Update Submit

June 8, 2016

Conditions

Surgical Wound InfectionSpinal DeformitySpinal Degeneration

Keywords

surgical site infectionspinal surgeryprophylactic antibioticspostoperative spinal drains

Outcome Measures

Primary Outcomes (1)

  • Incidence of Infection

    Patients were contacted and their medical records were reviewed for a minimum of one year after surgery in order to determine the incidence of postoperative infection. The Center for Disease Control's definition of surgical site infection was applied in determining infection rates.

    for one year after surgery

Study Arms (2)

24 Hour Antibiotics

Patients were randomized to receive 24 hours of postoperative antibiotics following spine surgery

Duration Antibiotics

Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery

Other: Antibiotic Protocol

Interventions

Antibiotic ProtocolOTHER

Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.

Duration Antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical spine patients of a single urban institution from 2008-2011

You may qualify if:

  • Must be scheduled to undergo spine surgery with likely drain placement (3 or more vertebral levels, dependent upon attending surgeon)
  • Must be over the age of 18
  • Must consent to randomized postoperative antibiotic treatment

You may not qualify if:

  • Does not receive a drain at the time of surgery
  • Surgery is cancelled
  • Infection is present at the time of initial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Related Publications (25)

  • 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: 15131430BACKGROUND

  • Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588.

    PMID: 14625336BACKGROUND

  • Drinkwater CJ, Neil MJ. Optimal timing of wound drain removal following total joint arthroplasty. J Arthroplasty. 1995 Apr;10(2):185-9. doi: 10.1016/s0883-5403(05)80125-1.

    PMID: 7798099BACKGROUND

  • Fang A, Hu SS, Endres N, Bradford DS. Risk factors for infection after spinal surgery. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1460-5. doi: 10.1097/01.brs.0000166532.58227.4f.

    PMID: 15959380BACKGROUND

  • Fletcher N, Sofianos D, Berkes MB, Obremskey WT. Prevention of perioperative infection. J Bone Joint Surg Am. 2007 Jul;89(7):1605-18. doi: 10.2106/JBJS.F.00901. No abstract available.

    PMID: 17606802BACKGROUND

  • Garcia S, Lozano ML, Gatell JM, Soriano E, Ramon R, Sanmiguel JG. Prophylaxis against infection. Single-dose cefonicid compared with multiple-dose cefamandole. J Bone Joint Surg Am. 1991 Aug;73(7):1044-8.

    PMID: 1874767BACKGROUND

  • Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021.

    PMID: 8893444BACKGROUND

  • Heydemann JS, Nelson CL. Short-term preventive antibiotics. Clin Orthop Relat Res. 1986 Apr;(205):184-7.

    PMID: 3698375BACKGROUND

  • Ho C, Sucato DJ, Richards BS. Risk factors for the development of delayed infections following posterior spinal fusion and instrumentation in adolescent idiopathic scoliosis patients. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2272-7. doi: 10.1097/BRS.0b013e31814b1c0b.

    PMID: 17873822BACKGROUND

  • Lonstein J, Winter R, Moe J, Gaines D. Wound infection with Harrington instrumentation and spine fusion for scoliosis. Clin Orthop Relat Res. 1973 Oct;(96):222-33. No abstract available.

    PMID: 4584242BACKGROUND

  • Massie JB, Heller JG, Abitbol JJ, McPherson D, Garfin SR. Postoperative posterior spinal wound infections. Clin Orthop Relat Res. 1992 Nov;(284):99-108.

    PMID: 1395319BACKGROUND

  • Mauerhan DR, Nelson CL, Smith DL, Fitzgerald RH Jr, Slama TG, Petty RW, Jones RE, Evans RP. Prophylaxis against infection in total joint arthroplasty. One day of cefuroxime compared with three days of cefazolin. J Bone Joint Surg Am. 1994 Jan;76(1):39-45. doi: 10.2106/00004623-199401000-00006.

    PMID: 8288664BACKGROUND

  • Nelson CL, Green TG, Porter RA, Warren RD. One day versus seven days of preventive antibiotic therapy in orthopedic surgery. Clin Orthop Relat Res. 1983 Jun;(176):258-63.

    PMID: 6851335BACKGROUND

  • Parker MJ, Livingstone V, Clifton R, McKee A. Closed suction surgical wound drainage after orthopaedic surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD001825. doi: 10.1002/14651858.CD001825.pub2.

    PMID: 17636687BACKGROUND

  • Parker MJ, Roberts CP, Hay D. Closed suction drainage for hip and knee arthroplasty. A meta-analysis. J Bone Joint Surg Am. 2004 Jun;86(6):1146-52. doi: 10.2106/00004623-200406000-00005.

    PMID: 15173286BACKGROUND

  • 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: 8938608BACKGROUND

  • Pollard JP, Hughes SP, Scott JE, Evans MJ, Benson MK. Antibiotic prophylaxis in total hip replacement. Br Med J. 1979 Mar 17;1(6165):707-9. doi: 10.1136/bmj.1.6165.707.

    PMID: 373841BACKGROUND

  • Rello J, Sa-Borges M, Correa H, Leal SR, Baraibar J. Variations in etiology of ventilator-associated pneumonia across four treatment sites: implications for antimicrobial prescribing practices. Am J Respir Crit Care Med. 1999 Aug;160(2):608-13. doi: 10.1164/ajrccm.160.2.9812034.

    PMID: 10430736BACKGROUND

  • Sankar B, Ray P, Rai J. Suction drain tip culture in orthopaedic surgery: a prospective study of 214 clean operations. Int Orthop. 2004 Oct;28(5):311-4. doi: 10.1007/s00264-004-0561-2. Epub 2004 Aug 14.

    PMID: 15316674BACKGROUND

  • Sculco TP. The economic impact of infected joint arthroplasty. Orthopedics. 1995 Sep;18(9):871-3. No abstract available.

    PMID: 8570494BACKGROUND

  • Thalgott JS, Cotler HB, Sasso RC, LaRocca H, Gardner V. Postoperative infections in spinal implants. Classification and analysis--a multicenter study. Spine (Phila Pa 1976). 1991 Aug;16(8):981-4. doi: 10.1097/00007632-199108000-00020.

    PMID: 1948385BACKGROUND

  • Viola RW, King HA, Adler SM, Wilson CB. Delayed infection after elective spinal instrumentation and fusion. A retrospective analysis of eight cases. Spine (Phila Pa 1976). 1997 Oct 15;22(20):2444-50; discussion 2450-1. doi: 10.1097/00007632-199710150-00023.

    PMID: 9355228BACKGROUND

  • Weinstein MA, McCabe JP, Cammisa FP Jr. Postoperative spinal wound infection: a review of 2,391 consecutive index procedures. J Spinal Disord. 2000 Oct;13(5):422-6. doi: 10.1097/00002517-200010000-00009.

    PMID: 11052352BACKGROUND

  • Williams DN, Gustilo RB. The use of preventive antibiotics in orthopaedic surgery. Clin Orthop Relat Res. 1984 Nov;(190):83-8.

    PMID: 6386263BACKGROUND

  • Wimmer C, Gluch H, Franzreb M, Ogon M. Predisposing factors for infection in spine surgery: a survey of 850 spinal procedures. J Spinal Disord. 1998 Apr;11(2):124-8.

    PMID: 9588468BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Baron S Lonner, MD

    NYU Hospital for Joint Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

May 31, 2012

Study Start

November 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2012

Last Updated

June 10, 2016

Record last verified: 2016-06

Locations

US(1)