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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01608854
Other study ID # NYUHJD08139
Secondary ID
Status Completed
Phase N/A
First received May 29, 2012
Last updated June 8, 2016
Start date November 2008
Est. completion date April 2012

Study information

Verified date June 2016
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Patients likely to receive postoperative spinal drains were enrolled and randomized preoperatively to receive one of two postoperative antibiotic treatments, either for 24 hours after surgery or for the duration of time the spinal drain was in place. If patients did not receive at least one spinal drain during surgery, they were excluded from the infection analysis and received the institutional standard of 24 hours of postoperative antibiotics. Patients that did receive drains were treated according to their randomization and followed for a minimum of one year for the incidence of surgical site infection. The diagnosis of surgical site infection was determined using the definition provided for the Center for Disease Control (CDC). All patients that developed surgical site infections were treated as appropriate by the attending physician.


Recruitment information / eligibility

Status Completed
Enrollment 539
Est. completion date April 2012
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Does not receive a drain at the time of surgery

- Surgery is cancelled

- Infection is present at the time of initial surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
United States NYU Hospital for Joint Diseases New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Drinkwater CJ, Neil MJ. Optimal timing of wound drain removal following total joint arthroplasty. J Arthroplasty. 1995 Apr;10(2):185-9. — View Citation

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. — View Citation

Fletcher N, Sofianos D, Berkes MB, Obremskey WT. Prevention of perioperative infection. J Bone Joint Surg Am. 2007 Jul;89(7):1605-18. Review. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Parker MJ, Livingstone V, Clifton R, McKee A. Closed suction surgical wound drainage after orthopaedic surgery. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001825. Review. — View Citation

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-A(6):1146-52. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Aug 14. — View Citation

Sculco TP. The economic impact of infected joint arthroplasty. Orthopedics. 1995 Sep;18(9):871-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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