Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients

Breast Neoplasms Clinical Trial

Official title:

A Single Center Prospective Randomized Control Trial Investigating the Short-term and Long-term Effects of Intraoperative Prophylactic Antibiotics/Antiseptics on Surgical Outcomes in Chinese Post-mastectomy Breast Reconstruction Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03742908
• Other study ID #: E2018124
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2018
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Shanshan He
• Phone: +86-22-23340123
• Email: ssh85[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to investigate different approaches of local application of antibiotics/antiseptics intraoperatively in Chinese patients undergoing post-mastectomy implant based breast reconstruction, and aims to single out an intervention method that limits the use of antibiotics and maintains low rates of surgical site infection and capsular contracture. Patients who undergo post mastectomy breast reconstruction in the breast reconstruction department in Tianjin Medical University Cancer Institute and Hospital are eligible to enter the study.

Description:

There is an ongoing trend towards implant based breast reconstruction in post-mastectomy patients in China. In 2015, more than 60% of patients undergoing breast reconstruction in Tianjin Medical University Cancer Institute and Hospital opted for implant based breast reconstruction. One of the major complications in implant based breast reconstruction is infection, which could cause implant explantation, delay the time to adjuvant therapies in breast cancer patients, and inflict adverse psychological effects. Although empirical intravenous and/or oral antibiotics are suggested peri-operatively, local applications of antibiotics/antiseptics and their combinations are applied differently in many medical centers worldwide, and some even suggest against the use of intraoperative local antibiotics. Furthermore, there is no consensus as to the local application of antibiotics intraoperatively for breast reconstruction patients in Chinese population. We therefore designed an open-label prospective randomized control trial in our Chinese patient population to investigate the effects of three different approaches of intraoperative surgical site intervention with antibiotics and or antiseptics. In each groups, all peri-operative interventions are standardized to best reduce bias. Short-term infection rate and long-term capsular contracture rate will be observed in the hope of singling out the best modality in our medical center to integrate into the overall comprehensive treatment for female breast cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 291
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent mastectomy and eligible for implant-based breast reconstructions

• 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:

• Metastatic breast cancer

• 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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Cefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Alderman A, Gutowski K, Ahuja A, Gray D; Postmastectomy Expander Implant 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-55e. doi: 10.1097/PRS.0000000000000541. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Phillips BT, Halvorson EG. Antibiotic Prophylaxis following Implant-Based Breast Reconstruction: What Is the Evidence? Plast Reconstr Surg. 2016 Oct;138(4):751-7. doi: 10.1097/PRS.0000000000002530. Review. — View Citation

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. — View Citation

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):1223-30. doi: 10.1097/PRS.0b013e31828bd377. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of minor surgical site infection	the reconstructed breasts present with redness, edema, pain and rise in skin temperature by observation, drainage or wound secretion microbiology culture are positive, the symptoms are relieved by oral antibiotics.	assessed up to 3 months post-op
Primary	Occurrence of major surgical site infection	the reconstructed breasts present with redness, edema, pain and rise in skin temperature by observation, drainage or wound secretion microbiology culture are positive, the symptoms are relieved by intravenous antibiotics or demand surgical interventions such as explantation or change of implant.	assessed up to 3 months post-op
Primary	Occurrence of capsular contracture	Hardness, pain, and or changes of shape/volume of the reconstructed breasts both by observation or inspected by breast imaging .The grade of capsular contracture is recorded in baker's grading(I-IV).	assessed from 3 months post-op up to 2 years post-op or until the trial ends, whichever comes first
Secondary	Occurrence of flap necrosis	Complete or partial flap necrosis at the surgical site by surgeon's observation;	assessed up to 1 months post-op
Secondary	Occurrence of hematoma	Peri-prosthetic hematoma observed by hematic drainage and reduced Hematocrit count comparing to normal range;	assessed up to 72 hours post-op
Secondary	Occurrence of peri-prosthetic seroma	Peri-prosthetic seroma observed by clinical inspection and/or breast imaging;	from 3 months post-op up to 2 years post-op or until the trial ends
Secondary	Baseline and changes of patient's evaluation	Patient oriented aesthetic and overall satisfaction evaluation using Breast-Q questionnaires (implant reconstructive module)	evaluate at 6 months as baseline, repeated evaluation at 12 months and 24 months post-op or until the trial ends, whichever comes first, to record changes