Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
Condition: Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesized that revision clean head & neck surgery may have a higher rate of wound
      infection that may be lowered with prophylactic antibiotic treatment.
    

Detailed description: 
      Surgical wound infection (SWI) is a common complication in many operations, including head
      and neck (H&N) surgery, with reported rates ranging between 3.5 to 87%. While prophylactic
      antibiotic use has been shown to decrease SWI in clean-contaminated and contaminated surgery,
      its use in clean surgery is debatable. In most types of clean surgery the value of
      prophylactic antibiotics is minimal, however in some cases it might be justified, including
      in radical neck dissections, in a previously irradiated neck, those with a tracheostomy and
      immunosuppressed patients - although there is no consensus regarding these risk factors.

      Previous research has shown that adherence to guidelines regarding prophylactic antibiotic
      use is lacking, with one study showing a greater than 40% rate of inappropriate antibiotic
      administration. This may be partially attributed to some patients having other risk factors,
      not covered by existing guidelines.

      One such risk factor is previous H&N surgery. While there are no studies addressing this
      issue in H&N surgeries, a study in clean neurosurgical operations has shown an almost
      trice-fold increase in SWI rates in some operations (4% vs. 13%).

      The purpose of this study is to investigate the effect of prophylactic antibiotic use in
      repeat clean H&N surgery.

      This is a double-blind, randomized, placebo-controlled study. The study will be conducted at
      the Otolaryngology department in Rabin Medical Center, Petah Tikva.

      Patients will be randomly assigned to 2 groups, with each group composed of 50 patients: a
      study group which will receive 1 dose of intravenous Cefazolin 1 gram/2 gram if body mass
      index > 40 or a control group which will receive 1 dose of placebo. The drug/placebo will be
      given 30-60 minutes prior to incision. Previous studies have shown no benefit for longer
      duration of prophylactic antibiotic coverage. Both the study drug and placebo will be
      prepared by a designated nurse from the department. The nurse will use a randomization site
      (www.random.org with min set to 1 and max set to 1000) to give each participant a number. A
      predefined Excel table will contain an assignment of each number to one of the groups. Only
      this nurse will know the assignment of each patient and she will not be assessing the patient
      post-operatively. The patients, surgeons and researchers will be blinded to the patients'
      assignments.

      The status of the surgical wound will be assessed daily during hospitalization and again on
      the planned follow-up visit 3-4 weeks after discharge. During the follow-up visit, patients
      will be questions regarding symptoms and signs of SWI and antibiotic prescriptions given
      during the post-operative period.

      SWI diagnosis will be according to the Center for Disease Control's "guideline for surgical
      site infection". Treatment of SWI will be according to regular department protocols (with no
      regard to study allocation).
    

Intervention name(s): Cefazolin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antibiotic; Placebo
Other intervention name(s): Cefamezine
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: head and neck surgery; surgical wound infection; antibiotic prophylaxis