Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial

• Published in: Trials 2013-02, Vol.14 (1), p.58-58
• Main Authors: Veiga, Daniela Francescato, Veiga-Filho, Joel, Damasceno, Carlos Américo Veiga, Sales, Edilaine Maria Leci, Morais, Thiago Bezerra, Almeida, Wânia Eliza, Novo, Neil Ferreira, Ferreira, Lydia Masako
• Format: Article
• Language: English
• Subjects: Analysis; Bandages - adverse effects; Brazil; Breast Neoplasms - surgery; Clinical Protocols; Female; Humans; Infection Control - methods; Mammaplasty - adverse effects; Mastectomy; Patient Satisfaction; Prospective Studies; Research Design; Risk factors; Skin; Skin - microbiology; Statistics; Study Protocol; Surgical dressings; Surgical Wound Infection - microbiology; Surgical Wound Infection - prevention & control; Surgical wound infections; Time Factors; Treatment Outcome; Wound Healing
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-14-58

One of the major risk variables for surgical site infection is wound management. Understanding infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes. The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization. Patients' perception at self-assessment will also be analyzed. This is a two-arm randomized controlled trial. Two hundred breast cancer patients undergoing immediate or delayed breast reconstruction will be prospectively enrolled. Patients will be randomly allocated to group I (dressing removed on postoperative day one) or group II (dressing removed on postoperative day six). Surgical site infections will be defined by standard criteria from the Centers for Disease Control and Prevention (CDC). Skin colonization will be assessed by culture of samples collected at predefined time points. Patients will score dressing wear time with regard to safety, comfort and convenience. The evidence to support dressing standards for breast surgery wounds is empiric and scarce. CDC recommends protecting, with a sterile dressing for 24 to 48 hours postoperatively, a primarily closed incision, but there is no recommendation to cover this kind of incision beyond 48 hours, or on the appropriate time to shower or bathe with an uncovered incision. The results of the ongoing trial may support standard recommendations regarding dressing wear time after breast reconstruction. ClinicalTrials.gov identifier: http://NCT01148823.