Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
NCT ID: NCT03742908
Last Updated: 2018-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
291 participants
INTERVENTIONAL
2018-06-16
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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saline control
Implant immersion with 100 ml sterile saline (0.9%) for 10 minutes; Breast pocket irrigation (IRRI) with 100ml type III Anerdian for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards. No antibiotics is used.
No interventions assigned to this group
Cefazolin/clindamycin immersion
Implant immersion: implant is immersed with 200mg cefazolin in 100 ml sterile saline (0.9%) for 10 minutes, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead for immersion; Breast pocket irrigation (IRRI) with100ml type III Anerdian for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards
Cefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation
Cefazolin/clindamycin immersion+ IRRI
Implant immersion: implant is immersed with 200mg cefazolin in 100 ml sterile saline (0.9%) for 10 minutes, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead for immersion; Breast pocket irrigation (IRRI): breast pocket is irrigated with100ml type III Anerdian plus 200mg cefazolin in 100 ml sterile saline (0.9%) for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead of cefazolin
Cefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation
Interventions
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Cefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky Performance Status (KPS) larger than 70
* No severe deficiency in hematological, cardiovascular system, no immunodeficiency, no severe abnormal liver or kidney function
Exclusion Criteria
* Local or systemic infection within 30 days prior to breast reconstruction surgery
* Local, oral or systemic administration of any form of antibiotics within 30 days prior to breast reconstruction surgery
* Pre-operative complete blood count shows white blood cell (WBC) count \>10\*10\^9/L, Neutrophil cell (N) count \> 7.5\*10\^9/L or N%\>80%
* Pre-operative blood procalcitonin (PCT) higher than upper limit of the normal range
* Past history with injection breast augmentation
FEMALE
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Jian Yin
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Kummerow KL, Du L, Penson DF, Shyr Y, Hooks MA. Nationwide trends in mastectomy for early-stage breast cancer. JAMA Surg. 2015 Jan;150(1):9-16. doi: 10.1001/jamasurg.2014.2895.
Piper ML, Roussel LO, Koltz PF, Wang F, Singh K, Chin R, Sbitany H, Langstein HN. Characterizing infections in prosthetic breast reconstruction: A validity assessment of national health databases. J Plast Reconstr Aesthet Surg. 2017 Oct;70(10):1345-1353. doi: 10.1016/j.bjps.2017.05.004. Epub 2017 May 18.
Constantine RS, Constantine FC, Rohrich RJ. The ever-changing role of biofilms in plastic surgery. Plast Reconstr Surg. 2014 Jun;133(6):865e-872e. doi: 10.1097/PRS.0000000000000213.
Rubino C, Brongo S, Pagliara D, Cuomo R, Abbinante G, Campitiello N, Santanelli F, Chessa D. Infections in breast implants: a review with a focus on developing countries. J Infect Dev Ctries. 2014 Sep 12;8(9):1089-95. doi: 10.3855/jidc.3898.
Reish RG, Damjanovic B, Austen WG Jr, Winograd J, Liao EC, Cetrulo CL, Balkin DM, Colwell AS. Infection following implant-based reconstruction in 1952 consecutive breast reconstructions: salvage rates and predictors of success. Plast Reconstr Surg. 2013 Jun;131(6):1223-1230. doi: 10.1097/PRS.0b013e31828bd377.
Alderman A, Gutowski K, Ahuja A, Gray D; Postmastectomy ExpanderImplant Breast Reconstruction Guideline Work Group. ASPS clinical practice guideline summary on breast reconstruction with expanders and implants. Plast Reconstr Surg. 2014 Oct;134(4):648e-655e. doi: 10.1097/PRS.0000000000000541.
Barr SP, Topps AR, Barnes NL, Henderson J, Hignett S, Teasdale RL, McKenna A, Harvey JR, Kirwan CC; Northwest Breast Surgical Research Collaborative. Infection prevention in breast implant surgery - A review of the surgical evidence, guidelines and a checklist. Eur J Surg Oncol. 2016 May;42(5):591-603. doi: 10.1016/j.ejso.2016.02.240. Epub 2016 Feb 27.
Phillips BT, Fourman MS, Bishawi M, Zegers M, O'Hea BJ, Ganz JC, Huston TL, Dagum AB, Khan SU, Bui DT. Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial. J Am Coll Surg. 2016 Jun;222(6):1116-24. doi: 10.1016/j.jamcollsurg.2016.02.018. Epub 2016 Mar 4.
Phillips BT, Halvorson EG. Antibiotic Prophylaxis following Implant-Based Breast Reconstruction: What Is the Evidence? Plast Reconstr Surg. 2016 Oct;138(4):751-757. doi: 10.1097/PRS.0000000000002530.
Huang N, Liu M, Yu P, Wu J. Antibiotic prophylaxis in prosthesis-based mammoplasty: a systematic review. Int J Surg. 2015 Mar;15:31-7. doi: 10.1016/j.ijsu.2015.01.020. Epub 2015 Jan 29.
Gowda AU, Chopra K, Brown EN, Slezak S, Rasko Y. Preventing Breast Implant Contamination in Breast Reconstruction: A National Survey of Current Practice. Ann Plast Surg. 2017 Feb;78(2):153-156. doi: 10.1097/SAP.0000000000000822.
Frois AO, Harbour PO, Azimi F, Young J, Chan B, Mak C, Warrier S. The Role of Antibiotics in Breast Pocket Irrigation and Implant Immersion: A Systematic Review. Plast Reconstr Surg Glob Open. 2018 Sep 14;6(9):e1868. doi: 10.1097/GOX.0000000000001868. eCollection 2018 Sep.
Other Identifiers
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E2018124
Identifier Type: -
Identifier Source: org_study_id
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