Clinical Trials Logo
  1. Home
  2. Surgical Wound Infection
  3. NCT00530400
  4. Details
NCT00530400 Clinical Trial

Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery

Surgical Wound Infection Clinical Trial

Official title:
Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00530400
Other study ID # CFX93LS06
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2007
Last updated September 14, 2007
Start date April 1994
Est. completion date March 2000

Study information
Verified date September 2007
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority Switzerland: Institut suisse des produits thérapeutiques
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk

Recruitment information / eligibility
Status Completed
Enrollment 1369
Est. completion date March 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Age older than 18

- spinal surgery for herniated disk

Exclusion Criteria:

- known or suspected hypersensitivity to cephalosporins

- type I hypersensitivity to betalactamic antibiotics

- severe renal function impairment

- acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression

- antibiotic therapy for concomitant infection at the time of surgery

- pregnancy

- refusal to participate

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• cefuroxime
preoperative intravenous 1.5g cefuroxime
• placebo
preoperative intravenous placebo

Locations
Country Name City State
Switzerland Hôpitaux Universitaire de Genève Geneva
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne

Sponsors (3)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois GlaxoSmithKline, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of a surgical site infection 6 months
Secondary Occurrence of a post-operative infection other than surgical site infection 6 monts
Secondary Serious adverse event 6 months
See also
  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
Not yet recruiting NCT01457859 - Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery Phase 4
Completed NCT01340534 - Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection Phase 3
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