Prophylactic antibiotics for excision of premalignant vulvar lesions: A pilot randomized controlled trial.
Mary M MullenWhitney R GritherHannah MillimetDavid G MutchAndrea R HagemannCarolyn K McCourtMatthew A PowellPremal H ThakerDineo KhabeleLindsay M KurokiPublished in: Gynecologic oncology reports (2024)
No prospective data have been described to inform guidelines on antibiotic prophylaxis for partial vulvectomies. Thus, we conducted a single-center, pilot, double-blind randomized controlled trial to assess the effectiveness of prophylactic antibiotics to prevent wound complications after partial vulvectomies. Patients were randomly assigned 1:1 to preoperative antibiotics or no preoperative antibiotics. The primary outcome of 30-day postoperative wound complications occurred in 31 (62 %) of all patients, with no differences between groups. The most common wound complications were superficial separation (54.2 % antibiotic prophylaxis vs. 65.3 % no prophylaxis, p = 0.37) and surgical site infection (0 % antibiotic prophylaxis vs 7.7 % no prophylaxis, p = 0.49). However, this study was limited by differences in patient characteristics between the groups. This study provides data to perform power calculations for a trial examining the effect of preoperative antibiotics on surgical site infection.
Keyphrases
- surgical site infection
- randomized controlled trial
- study protocol
- patients undergoing
- end stage renal disease
- double blind
- newly diagnosed
- risk factors
- electronic health record
- squamous cell carcinoma
- systematic review
- ejection fraction
- phase iii
- radiation therapy
- lymph node
- peritoneal dialysis
- wound healing
- molecular dynamics
- molecular dynamics simulations
- open label
- placebo controlled
- data analysis
- patient reported