Comparison of Complications Following Implant-Based Breast Reconstruction Using Triple Antibiotic Solution versus Low Concentration Chlorhexidine Gluconate Solution
Background: Prevention of infection and capsular contracture remains a primary goal of implant-based breast reconstruction (IBBR). Previous studies have demonstrated improved outcomes with the use of triple-antibiotic solution (TAS) for breast pocket irrigation, but ready-to-use products have recently gained popularity. The purpose of this study is to compare outcomes following IBBR between TAS and low-concentration chlorhexidine gluconate (CHG) solutions. Methods: This is a retrospective analysis of 690 consecutive patients undergoing IBBR from 2008-2017. The TAS (n = 346) irrigation solution was composed of 1 g cefazolin, 80 mg gentamicin and 50,000 U bacitracin diluted in 500 mL of normal saline; the CHG (n = 344) irrigation solution was the commercially-available product Irrisept？(0.05% chlorhexidine gluconate in sterile water, Irrimax Corporation, Lawrenceville, GA). Comparisons were made between demographic and clinical variables. Complications were recorded and statistical analysis, including multivariate regression analysis, was performed. Results: The TAS group underwent significantly more skin-sparing mastectomies, adjuvant chemotherapy/radiation and less direct-to-implant reconstruction than the CHG group. The CHG group experienced a significantly lower incidence of total complications (22.4% vs. 31.8%, p = 0.006), minor complications (8.7% vs. 16.5%, p = 0.003), infection (6.4% vs. 12.7%, p = 0.006) and seroma (2.6% vs. 6.9%, p = 0.011). There was a significantly increased rate of delayed wound healing in the CHG group. Multivariate analysis showed that the use of CHG solution significantly decreased the odds of any complication by 1.6-fold (OR 0.637, 95% CI 0.414 - 0.977) and the odds of infection by 2.4-fold (OR 0.420, 95% CI 0.218 - 0.809). There were no statistically significant differences in rates of capsular contracture or other complications. Conclusions: The use of CHG as a pocket irrigant in post-mastectomy breast reconstruction is a reasonable alternative to other solutions, in efforts to minimize prosthetic based complications.
References
[1]
Cancer Stat Facts: Female Breast Cancer (2018) National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program.
[2]
Miller, A.M., Steiner, C.A., Barrett, M.L., Fingar, K.R. and Elixhauser, A. (2006) Breast Reconstruction Surgery for Mastectomy in Hospital Inpatient and Ambulatory Settings, 2009-2014: Statistical Brief #228. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville.
[3]
American Society of Plastic Surgeons Plastic Surgery Statistics Report (2017) ASPS National Clearinghouse of Plastic Surgery Procedural Statistics, 2017.
[4]
Ilonzo, N., Tsang, A., Tsantes, S., Estabrook, A. and Thu Ma, A.M. (2017) Breast Reconstruction after Mastectomy: A Ten-Year Analysis of Trends and Immediate Postoperative Outcomes. Breast, 32, 7-12. https://doi.org/10.1016/j.breast.2016.11.023
[5]
Cohen, J.B., Carroll, C., Tenenbaum, M.M. and Myckatyn, T.M. (2015) Breast Implant-Associated Infections: The Role of the National Surgical Quality Improvement Program and the Local Microbiome. Plastic and Reconstructive Surgery, 136, 921-929. https://doi.org/10.1097/PRS.0000000000001682
[6]
Forster, N.A., Kunzi, W. and Giovanoli, P. (2013) The Reoperation Cascade after Breast Augmentation with Implants: What the Patient Needs to Know. Journal of Plastic, Reconstructive & Aesthetic Surgery, 66, 313-322. https://doi.org/10.1016/j.bjps.2012.09.033
[7]
Hidalgo, D.A. and Sinno, S. (2016) Current Trends and Controversies in Breast Augmentation. Plastic and Reconstructive Surgery, 137, 1142-1150. https://doi.org/10.1097/01.prs.0000481110.31939.e4
[8]
Ota, D., Fukuuchi, A., Iwahira, Y., et al. (2016) Identification of Complications in Mastectomy with Immediate Reconstruction Using Tissue Expanders and Permanent Implants for Breast Cancer Patients. Breast Cancer, 23, 400-406. https://doi.org/10.1007/s12282-014-0577-4
[9]
Ozturk, C.N., Ozturk, C., Soucise, A., et al. (2018) Expander/Implant Removal after Breast Reconstruction: Analysis of Risk Factors and Timeline. Aesthetic Plastic Surgery, 42, 64-72. https://doi.org/10.1007/s00266-017-1031-8
[10]
Song, J.H., Kim, Y.S., Jung, B.K., et al. (2017) Salvage of Infected Breast Implants. Archives of Plastic Surgery, 44, 516-522. https://doi.org/10.5999/aps.2017.01025
[11]
Adams, W.P., Rios, J.L. and Smith, S.J. (2006) Enhancing Patient Outcomes in Aesthetic and Reconstructive Breast Surgery Using Triple Antibiotic Breast Irrigation: Six-Year Prospective Clinical Study. Plastic and Reconstructive Surgery, 117, 30-36.
[12]
Alderman, A., Gutowski, K., Ahuja, A. and Gray, D. (2014) Postmastectomy Expander Implant Breast Reconstruction Guideline Work G. ASPS Clinical Practice Guideline Summary on Breast Reconstruction with Expanders and Implants. Plastic and Reconstructive Surgery, 134, 648e-655e. https://doi.org/10.1097/PRS.0000000000000541
[13]
Araco, A., Gravante, G., Araco, F., Delogu, D., Cervelli, V. and Walgenbach, K. (2007) Infections of Breast Implants in Aesthetic Breast Augmentations: A Single-Center Review of 3,002 Patients. Aesthetic Plastic Surgery, 31, 325-329. https://doi.org/10.1007/s00266-006-0156-y
[14]
Craft, R.O., Damjanovic, B. and Colwell, A.S. (2012) Evidence-Based Protocol for Infection Control in Immediate Implant-Based Breast Reconstruction. Annals of Plastic Surgery, 69, 446-450. https://doi.org/10.1097/SAP.0b013e31824a215a
[15]
Galdiero, M., Larocca, F., Iovene, M.R., et al. (2018) Microbial Evaluation in Capsular Contracture of Breast Implants. Plastic and Reconstructive Surgery, 141, 23-30. https://doi.org/10.1097/PRS.0000000000003915
[16]
Gowda, A.U., Chopra, K., Brown, E.N., Slezak, S. and Rasko, Y. (2017) Preventing Breast Implant Contamination in Breast Reconstruction: A National Survey of Current Practice. Annals of Plastic Surgery, 78, 153-156. https://doi.org/10.1097/SAP.0000000000000822
[17]
Giordano, S., Peltoniemi, H., Lilius, P. and Salmi, A. (2013) Povidone-Iodine Combined with Antibiotic Topical Irrigation to Reduce Capsular Contracture in Cosmetic Breast Augmentation: A Comparative Study. Aesthetic Surgery Journal, 33, 675-680. https://doi.org/10.1177/1090820X13491490
[18]
Zhadan, O. and Becker, H. (2018) Surgical Site Irrigation in Plastic Surgery. Aesthetic Surgery Journal, 38, 265-273. https://doi.org/10.1093/asj/sjx171
[19]
Rieger, U.M., Mesina, J., Kalbermatten, D.F., et al. (2013) Bacterial Biofilms and Capsular Contracture in Patients with Breast Implants. British Journal of Surgery, 100, 768-774. https://doi.org/10.1002/bjs.9084
[20]
Bartsich, S., Ascherman, J.A., Whittier, S., Yao, C.A. and Rohde, C. (2011) The Breast: A Clean-Contaminated Surgical Site. Aesthetic Surgery Journal, 31, 802-806. https://doi.org/10.1177/1090820X11417428
[21]
Viola, G.M., Raad, I.I. and Rolston, K.V. (2014) Breast Tissue Expander-Related Infections: Perioperative Antimicrobial Regimens. Infection Control & Hospital Epidemiology, 35, 75-81. https://doi.org/10.1086/674390
[22]
Phillips, B.T., Bishawi, M., Dagum, A.B., Khan, S.U. and Bui, D.T. (2013) A Systematic Review of Antibiotic Use and Infection in Breast Reconstruction: What Is the Evidence? Plastic and Reconstructive Surgery, 131, 1-13.
[23]
Ranganathan, K., Sears, E.D., Zhong, L., et al. (2018) Antibiotic Prophylaxis after Immediate Breast Reconstruction: The Reality of Its Efficacy. Plastic and Reconstructive Surgery, 141, 865-877. https://doi.org/10.1097/PRS.0000000000004204
[24]
McCullough, M.C., Chu, C.K., Duggal, C.S., Losken, A. and Carlson, G.W. (2016) Antibiotic Prophylaxis and Resistance in Surgical Site Infection after Immediate Tissue Expander Reconstruction of the Breast. Annals of Plastic Surgery, 77, 501-505. https://doi.org/10.1097/SAP.0000000000000275
[25]
Adams, W.P., Conner, W.C., Barton, F.E. and Rohrich, R.J. (2000) Optimizing Breast Pocket Irrigation: An in Vitro Study and Clinical Implications. Plastic and Reconstructive Surgery, 105, 9-43. https://doi.org/10.1097/00006534-200001000-00053
[26]
Adams, W.P., Rios, J.L. and Smith, S.J. (2006) Enhancing Patient Outcomes in Aesthetic and Reconstructive Breast Surgery Using Triple Antibiotic Breast Irrigation: Six-Year Prospective Clinical Study. Plastic and Reconstructive Surgery, 118, 46S-52S. https://doi.org/10.1097/01.prs.0000185671.51993.7e
[27]
Drinane, J.J., Chowdhry, T., Pham, T.H. and Ritter, E. (2017) Examining the Role of Antimicrobial Irrigation and Capsular Contracture: A Systematic Review and Meta-Analysis. Annals of Plastic Surgery, 79, 107-114. https://doi.org/10.1097/SAP.0000000000001134
[28]
Drinane, J.J., Kortes, M.J., Bergman, R.S. and Folkers, B.L. (2016) Evaluation of Antibiotic Irrigation versus Saline Irrigation in Reducing the Long-Term Incidence and Severity of Capsular Contraction after Primary Augmentation Mammoplasty. Annals of Plastic Surgery, 77, 32-36. https://doi.org/10.1097/SAP.0000000000000302
[29]
Burkhardt, B.R. and Demas, C.P. (1994) The Effect of Siltex Texturing and Povidone-Iodine Irrigation on Capsular Contracture around Saline Inflatable Breast Implants. Plastic and Reconstructive Surgery, 93, 123-128. https://doi.org/10.1097/00006534-199401000-00018
[30]
Burkhardt, B.R. and Eades, E. (1995) The Effect of Biocell Texturing and Povidone-Iodine Irrigation on Capsular Contracture around Saline-Inflatable Breast Implants. Plastic and Reconstructive Surgery, 96, 1317-1325. https://doi.org/10.1097/00006534-199511000-00013
[31]
McGuire, P., Reisman, N.R. and Murphy, D.K. (2017) Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants. Plastic and Reconstructive Surgery, 139, 1-9. https://doi.org/10.1097/PRS.0000000000002837
[32]
Yalanis, G.C., Liu, E.W. and Cheng, H.T. (2015) Efficacy and Safety of Povidone-Iodine Irrigation in Reducing the Risk of Capsular Contracture in Aesthetic Breast Augmentation: A Systematic Review and Meta-Analysis. Plastic and Reconstructive Surgery, 136, 687-698. https://doi.org/10.1097/PRS.0000000000001576
[33]
Wiener, T.C. (2013) Betadine and Breast Implants: An Update. Aesthetic Surgery Journal, 33, 615-617. https://doi.org/10.1177/1090820X13484036
[34]
Wiener, T.C. (2007) The Role of Betadine Irrigation in Breast Augmentation. Plastic and Reconstructive Surgery, 119, 12-15. https://doi.org/10.1097/01.prs.0000251088.51675.a8
[35]
Zambacos, G.J., Nguyen, D. and Morris, R.J. (2004) Effect of Povidone Iodine on Silicone Gel Breast Implants in Vitro: Implications for Clinical Practice. Plastic and Reconstructive Surgery, 114, 706-710. https://doi.org/10.1097/01.PRS.0000130972.59268.AA
[36]
Darouiche, R.O., Wall, M.J., Itani, K.M., et al. (2010) Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. The New England Journal of Medicine, 362, 18-26. https://doi.org/10.1056/NEJMoa0810988
[37]
Dumville, J.C., McFarlane, E., Edwards, P., Lipp, A., Holmes, A. and Liu, Z. (2015) Preoperative Skin Antiseptics for Preventing Surgical Wound Infections after Clean Surgery. Cochrane Database of Systematic Reviews, No. 4, CD003949. https://doi.org/10.1002/14651858.CD003949.pub4
[38]
Edmiston, C.E., Bruden, B., Rucinski, M.C., Henen, C., Graham, M.B. and Lewis, B.L. (2013) Reducing the Risk of Surgical Site Infections: Does Chlorhexidine Gluconate Provide a Risk Reduction Benefit? American Journal of Infection Control, 41, S49-S55. https://doi.org/10.1016/j.ajic.2012.10.030
[39]
Schmidt, K., Estes, C., McLaren, A. and Spangehl, M.J. (2018) Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis from Biofilm: An in Vitro Study. Clinical Orthopaedics and Related Research, 476, 648-653. https://doi.org/10.1007/s11999.0000000000000052
[40]
FDA (2017) FDA Drug Safety Communication: FDA Warns about Rare But Serious Allergic Reactions with the Skin Antiseptic Chlorhexidine Gluconate.
[41]
Rose, M.A., Garcez, T., Savic, S. and Garvey, L.H. (2019) Chlorhexidine Allergy in the Perioperative Setting: A Narrative Review. British Journal of Anaesthesia, 123, e95-e103. https://doi.org/10.1016/j.bja.2019.01.033
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？(0.05% chlorhexidine gluconate in sterile water, Irrimax Corporation, Lawrenceville, GA). Comparisons were made between demographic and clinical variables. Complications were recorded and statistical analysis, including multivariate regression analysis, was performed. Results: The TAS group underwent significantly more skin-sparing mastectomies, adjuvant chemotherapy/radiation and less direct-to-implant reconstruction than the CHG group. The CHG group experienced a significantly lower incidence of total complications (22.4% vs. 31.8%, p = 0.006), minor complications (8.7% vs. 16.5%, p = 0.003), infection (6.4% vs. 12.7%, p = 0.006) and seroma (2.6% vs. 6.9%, p = 0.011). There was a significantly increased rate of delayed wound healing in the CHG group. Multivariate analysis showed that the use of CHG solution significantly decreased the odds of any complication by 1.6-fold (OR 0.637, 95% CI 0.414 - 0.977) and the odds of infection by 2.4-fold (OR 0.420, 95% CI 0.218 - 0.809). There were no statistically significant differences in rates of capsular contracture or other complications. Conclusions: The use of CHG as a pocket irrigant in post-mastectomy breast reconstruction is a reasonable alternative to other solutions, in efforts to minimize prosthetic based complications.
