Abstract
BackgroundThe evidence to support dressing standards for breast surgery wounds is empiric and scarce.ObjectiveThis two-arm randomized clinical trial was designed to assess the effect of dressing wear time on surgical site infection (SSI) rates, skin colonization and patient perceptions.MethodsA total of 200 breast cancer patients undergoing breast reconstruction were prospectively enrolled. Patients were randomly allocated to group I (dressing removed on the first postoperative day, n = 100) or group II (dressing removed on the sixth postoperative day, n = 100). SSIs were defined and classified according to criteria from the Centers for Disease Control and Prevention. Samples collected before placing the dressing and after 1 day (group I) and 6 days (both groups) were cultured for skin colonization assessments. Patients preferences and perceptions with regard to safety, comfort and convenience were recorded and analyzed.ResultsA total of 186 patients completed the follow-up. The global SSI rate was 4.5%. Six patients in group I and three in group II had SSI (p = 0.497). Before dressing, the groups were similar with regard to skin colonization. At the sixth day, there was a higher colonization by coagulase-negative staphylococci in group I (p<0.0001). Patients preferred to keep dressing for six days (p<0.0001), and considered this a safer choice (p<0.05).ConclusionsDespite group I had a higher skin colonization by coagulase-negative staphylococci on the sixth postoperative day, there was no difference in SSI rates. Patients preferred keeping dressing for six days and considered it a safer choice.Trial RegistrationClinicalTrials.gov NCT01148823
Highlights
The evidence to support dressing standards for breast surgery wounds is empiric and scarce
Despite group I had a higher skin colonization by coagulase-negative staphylococci on the sixth postoperative day, there was no difference in surgical site infection (SSI) rates
Patients preferred keeping dressing for six days and considered it a safer choice
Summary
This is a two-arm parallel group randomized clinical trial. The study protocol has been published [35]. In October 2007, the Ethics Committee approved an initial protocol for a study of patients undergoing various kinds of clean plastic surgery procedures of the thorax, including breast reconstruction. Owing to the great heterogeneity of procedures, we were unable to attribute any differences in SSI rates, skin colonization or patient perceptions to the length of time that the dressing was kept in place. Another randomization in blocks of 40 patients was generated in 2009, with patients stratified by surgical procedure. Breast reconstruction patients, recruited after the stratification, were included in the present trial. DFV and JVF recruited and selected participants, FEMF, IVC and NLLP assigned participants to interventions
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