Antibiotics in Free Flaps Reconstructions
Condition: Postoperative Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to monitor and compare peri-operative problems and outcomes of
      reconstructive surgery with microvascular free flaps in the head and neck region between
      groups of patients treated with perioperative antibiotics and a group of patients without
      antibiotics.
    

Detailed description: 
      Study Design and Patient Recruitment All clinical investigations have been conducted
      according to the principles expressed in the Declaration of Helsinki. Patient consent was
      written. Any patient who required reconstructive surgery for oncological reasons within the
      oral cavity with microvascular free flaps was eligible. Patients receiving preoperative
      neoadjuvant or previous adjuvant radiation therapy in their medical history were not included
      in this study as the protocols available are not comparable in doses and effect on the
      irradiated tissue.14 A prospective study was initiated from July of 2007 to June 2012. All
      patients were prospectively evaluated.

      Postoperative Care The investigators standard regimen was to keep the patient sedated for one
      night on the intensive care unit and then transfer to the surgical ward. The specific
      intravenous antibiotic therapy was started 30 minutes before the operation and administered
      for 10 days.

      Data Analysis Recorded parameters included: age, sex, preoperative medical history, American
      society of Anesthesiologists classification of preoperative status 15, diagnosis, stage of
      disease, defect localisation, type of microvascular free flap, choice of recipient vessels,
      flap success, rate and number of operative revisions, primary or secondary reconstruction,
      type of previous treatment (radiation or surgery), type of previous neck dissection (if any),
      microvascular complications, the total operative time, wound healing disturbances subdivided
      into dehiscence and infection at the neck, region of reconstruction, or donor site, and
      prophylactic antibiotic agent, if used. Infection was defined as a purulent discharge at the
      wounds.

      Descriptive statistics for quantitative variables are given as the mean ± standard deviation.
      The data were analyzed with the "Statistical Package for the Social Sciences" software (IBM®
      SPSS® Statistics for Windows, Version 22.0; IBM Corp., Armonk, NY, USA). Figures are
      generated with SPSS and Microsoft® Office Excel (Microsoft Excel for Windows, release 11.0,
      2003, Microsoft Corporation, Redmond, WA, USA). Multiple linear regression analyses were used
      to determine factors independently associated with the dependent variable wound infection or
      wound healing disturbances. 95% confidence intervals (95% CI) are also given. Differences
      were considered to be statistically significant for a two-sided p-value of less than 0.05.
    

Intervention name(s): antibiotic (use of penicilline, unacid, cefuroxime)
Intervention type(s): Drug
Intervention description(s): prophylactic antibiotics
Other intervention name(s): use of penicilline, unacid, cefuroxime
Intervention MeSH terms: Anti-Bacterial Agents; Cefuroxime; Cefuroxime axetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention