Abstract
Background
In this 2-site randomized trial, we investigated the effect of antiseptic drain care on bacterial colonization of surgical drains and infection after immediate prosthetic breast reconstruction.
Methods
With IRB approval, we randomized patients undergoing bilateral mastectomy and reconstruction to drain antisepsis (treatment) for one side, with standard drain care (control) for the other. Antisepsis care included both: chlorhexidine disc dressing at drain exit site(s) and irrigation of drain bulbs twice daily with dilute sodium hypochlorite solution. Cultures were obtained from bulb fluid at 1 week and at drain removal, and from the subcutaneous drain tubing at removal. Positive cultures were defined as ≥1+ growth for fluid and >50 CFU for tubing.
Results
Cultures of drain bulb fluid at 1 week (the primary endpoint) were positive in 9.9 % of treatment sides (10 of 101) versus 20.8 % (21 of 101) of control sides (p = 0.02). Drain tubing cultures were positive in 0 treated drains versus 6.2 % (6 of 97) of control drains (p = 0.03). Surgical site infection occurred within 30 days in 0 antisepsis sides versus 3.8 % (4 of 104) of control sides (p = 0.13), and within 1 year in three of 104 (2.9 %) of antisepsis sides versus 6 of 104 (5.8 %) of control sides (p = 0.45). Clinical infection occurred within 1 year in 9.7 % (6 of 62) of colonized sides (tubing or fluid) versus 1.5 % (2 of 136) of noncolonized sides (p = 0.03).
Conclusions
Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains, and reduced drain colonization was associated with fewer infections.
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Acknowledgment
Funds for this study were provided by Ethicon, Inc. This project was also supported by NIH Center for Translational Science Activities grant support (UL1 TR000135). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. Sincere thanks to Jill Randolph R.Ph. and Sue McCluskey R.Ph. for preparation of dilute Dakin’s solution, Lisa M. Nyre, Sherry M. Ihde, and David T. Lynch in Microbiology, and to Marilyn Churchward for assistance with manuscript preparation. Most importantly, this study was made possible by the individuals who elected to participate in this research study.
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ClinicalTrials.gov Identifier: NCT 01286168
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Degnim, A.C., Hoskin, T.L., Brahmbhatt, R.D. et al. Randomized Trial of Drain Antisepsis After Mastectomy and Immediate Prosthetic Breast Reconstruction. Ann Surg Oncol 21, 3240–3248 (2014). https://doi.org/10.1245/s10434-014-3918-9
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DOI: https://doi.org/10.1245/s10434-014-3918-9