Surgical Wound Infection Clinical Trial
Official title:
Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | NYU Hospital for Joint Diseases | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
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 all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05529173 -
Povidone-Iodine for Nasal Decolonization
|
Phase 4 | |
Recruiting |
NCT03295955 -
Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy
|
N/A | |
Not yet recruiting |
NCT05276687 -
Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
|
Phase 4 | |
Completed |
NCT02776774 -
Topical Antibiotic Treatment for Spine Surgical Site Infection
|
||
Terminated |
NCT00386477 -
Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
|
N/A | |
Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Recruiting |
NCT05077592 -
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
|
Phase 4 | |
Completed |
NCT03148067 -
Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
|
||
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Completed |
NCT01890720 -
Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section
|
N/A | |
Recruiting |
NCT06319235 -
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
|
Phase 1/Phase 2 | |
Completed |
NCT02919410 -
Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial
|
N/A | |
Completed |
NCT02020018 -
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
|
N/A | |
Completed |
NCT01741649 -
Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
|
N/A | |
Completed |
NCT01340534 -
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
|
Phase 3 | |
Not yet recruiting |
NCT01457859 -
Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery
|
Phase 4 | |
Completed |
NCT03365219 -
Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections
|
N/A | |
Completed |
NCT01026259 -
Local Warming of Surgical Incisions
|
Phase 3 | |
Completed |
NCT03574090 -
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
|
Phase 4 | |
Completed |
NCT03199911 -
Topical Antibiotic Prophylaxis for Eyelids
|
Phase 4 |