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Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis

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ClinicalTrials.gov Identifier: NCT01790529
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : September 29, 2016
Sponsor:
Collaborator:
Cantonal Hospital of Aarau, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

Surgical site infections (SSI) are the most frequent hospital acquired infections in patients who underwent surgery. With regards to the increasing financial restraint in patient care, the socio-economic burden of SSI in the public health sector and its prevention gains in importance.

The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior to the skin incision significantly reduces the risk of SSI, but the correct time point of drug administration remains unclear. Most studies recommend application of SAP directly prior to skin incision. Other studies, however, suggest that this is too late and more time between administration of the SAP and skin incision is necessary for optimal SSI prevention. A large cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes prior to skin incision.

Due to the obvious importance of this controversy, we want to answer this question with a clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room located in front of the actual operating theatre, where the patient gets anesthesia. Therefore, the application of SAP will take place early, approximately between 75 and 30 minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre, which on average occurs later (approximately within the last 30 minutes before skin incision).

We test the hypothesis that strategy A is more effective in preventing SSI than strategy B. We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at each study site and 2500 per study group). All patients will be followed in the hospital for SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as hip endoprosthesis or meshes). We expect this study to be completed within approximately 3 years.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Procedure: Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) Procedure: Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis
Study Start Date : February 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Early Prophylaxis
Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision)
Procedure: Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision)
Active Comparator: Late Prophylaxis
Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)
Procedure: Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)



Primary Outcome Measures :
  1. Surgical Site Infection (SSI) [ Time Frame: 30 days ]
    Surgical Site Infection within 30 days after index surgery


Secondary Outcome Measures :
  1. All-cause 30 day mortality [ Time Frame: 30 days ]
  2. Length of hospital stay [ Time Frame: 1 year ]
  3. Economic burden of SSI [ Time Frame: 1 year ]
  4. Nosocomial infections [ Time Frame: 1 year ]
  5. In-hospital complications [ Time Frame: 1 year ]
    according to the Clavien-Dindo-Classification

  6. Surgical Site Infection (SSI) [ Time Frame: 1 year ]
    Surgical Site Infection within 1 year after surgery only for implant surgeries



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Inpatient visceral, vascular and trauma procedures
  • SAP indicated according to clinical standards (CDC guidelines for surgical wound classification)
  • informed consent

Exclusion Criteria:

  • Contraindication for study drugs
  • Pre-existing antibiotic therapy within 14 days of surgery
  • Any doubt that patients can make the decision to participate fully informed due to cognitive impairment, such as in critically ill or demented patients.
  • Emergency procedures with planned incision within 2 hours after the surgeon indicated the procedure
  • Participation in other studies that could potentially interfere with the present one (according to the ethics committee)
  • Combined surgery including surgical subspecialties other than the above mentioned

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790529


Locations
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Switzerland
University Hospital Basel
Basel, Baselstadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Cantonal Hospital of Aarau, Switzerland
Investigators
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Principal Investigator: Walter P. Weber, MD University Hospital Basel, Basel 4031 Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01790529    
Other Study ID Numbers: SSI-19/12
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infections
Postoperative Complications
Pathologic Processes
Metronidazole
Cefuroxime
Cefuroxime axetil
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents