SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter, Double-blinded RCT.

NCT04577846 | Unknown Phase 3 DMC

• 1 other identifier: 2020-3627-1407
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 3

Brief Summary

Breast cancer is the second most prevalent malignancy in the world and an important component of treatment warrants surgical procedures such as mastectomy. Surgical site infections after breast surgery may range from 1-26%, which is high for surgeries that are considered "clean procedures", as defined by the Centers for Disease Control and Prevention (CDC) wound classification system. Prophylactic antibiotics given before the surgical incision as per Joint Commissions SCIP (Surgical Care Improvement Project) guidelines, have been shown to decrease the rate of postoperative infections in a vast number of patients. There is however, no clear consensus due to lack of evidence on continuation (duration) of prophylactic antibiotics in patients undergoing mastectomy with indwelling drains, and thus antibiotic prescribing practices may vary among breast as well as reconstructive surgeons. In this trial all patients undergoing mastectomy without immediate reconstruction will receive a single prophylactic dose of preoperative antibiotic, and subsequently, the patients will be randomized to either continue the prophylactic antibiotics or receive a placebo for the duration of indwelling drains. The aim of this trial is to compare the difference in SSI rates between these two study arms as the main outcome. In addition, the factors associated with differing rates of SSI in the intervention and control group will also be identified.

Conditions

Surgical Site Infection

Keywords

mastectomy; antibiotic prophylaxis; surgical site infection; drains

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (SSI)

  Standard CDC criteria: 1. purulent drainage from the incision or drain site; 2. organisms isolated from an aseptically obtained culture of fluid or tissue; 3. deliberate opening of the incision by a surgeon in patients having either tenderness, localized swelling, redness, or warmth; or 4. diagnosis of SSI by the surgeon or study wound assessor or 5. prescription of therapeutic antibiotics; 6. Patients clinically diagnosed and documented to have cellulitis.

  up to 30 days.

Other Outcomes (1)

• Rates of antibiotic associated side-effects

  will be assessed during the follow-up visits between postoperative days 4-8 days for the 1st postoperative visit and subsequently at each routine postoperative visit while the drain is in place, for a maximum of 30 days.

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

The intervention arm will be administered, either Cefazolin iv every 8 hours while NPO or cefalexin 500 mg q8 hours per oral if tolerating a diet.

Drug: Cephalexin 500 MG

Control

PLACEBO COMPARATOR

Controls will be provided with initially IV placebo while NPO and then with a placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.

Drug: Placebo

Interventions

Cephalexin 500 MG DRUG

Cefalexin 500 mg PO q8 hours will be continued for the duration of the indwelling drains which usually is about 14 days.

Intervention Arm

Placebo DRUG

A placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Undergo breast reconstruction
• Who have other medical indications for which they must remain on antibiotics for more than the single preoperative dose
• Those with any history of allergies to beta-lactam drug
• Patients who had an open breast or axillary biopsy/breast conservation in the last 30 days on the ipsilateral side.

Sponsors & Collaborators

• Aga Khan University: lead
• Liaquat National Hospital & Medical College: collaborator
• Dow University of Health Sciences: collaborator

Study Sites (3)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

Location

Aga Khan University Hospital

Karachi, Sindh, 7480 0, Pakistan

Location

Liaquat National Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (20)

• Zeeshan S, Ali B, Ahmad K, Chagpar AB, Sattar AK. Clinicopathological Features of Young Versus Older Patients With Breast Cancer at a Single Pakistani Institution and a Comparison With a National US Database. J Glob Oncol. 2019 Mar;5:1-6. doi: 10.1200/JGO.18.00208.

  PMID: 30860954 BACKGROUND

• Vilar-Compte D, Jacquemin B, Robles-Vidal C, Volkow P. Surgical site infections in breast surgery: case-control study. World J Surg. 2004 Mar;28(3):242-6. doi: 10.1007/s00268-003-7193-3. Epub 2004 Feb 17.

  PMID: 14961196 BACKGROUND

• Throckmorton AD, Boughey JC, Boostrom SY, Holifield AC, Stobbs MM, Hoskin T, Baddour LM, Degnim AC. Postoperative prophylactic antibiotics and surgical site infection rates in breast surgery patients. Ann Surg Oncol. 2009 Sep;16(9):2464-9. doi: 10.1245/s10434-009-0542-1. Epub 2009 Jun 9.

  PMID: 19506959 BACKGROUND

• Degnim AC, Scow JS, Hoskin TL, Miller JP, Loprinzi M, Boughey JC, Jakub JW, Throckmorton A, Patel R, Baddour LM. Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. Ann Surg. 2013 Aug;258(2):240-7. doi: 10.1097/SLA.0b013e31828c0b85.

  PMID: 23518704 BACKGROUND

• Angarita FA, Acuna SA, Torregrosa L, Tawil M, Escallon J, Ruiz A. Perioperative variables associated with surgical site infection in breast cancer surgery. J Hosp Infect. 2011 Dec;79(4):328-32. doi: 10.1016/j.jhin.2011.08.006. Epub 2011 Nov 3.

  PMID: 22054593 BACKGROUND

• Jones DJ, Bunn F, Bell-Syer SV. Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery. Cochrane Database Syst Rev. 2014 Mar 9;(3):CD005360. doi: 10.1002/14651858.CD005360.pub4.

  PMID: 24609957 BACKGROUND

• Felippe WA, Werneck GL, Santoro-Lopes G. Surgical site infection among women discharged with a drain in situ after breast cancer surgery. World J Surg. 2007 Dec;31(12):2293-9; discussion 2300-1. doi: 10.1007/s00268-007-9248-3.

  PMID: 17917771 BACKGROUND

• Gao YX, Xu L, Ye JM, Wang DM, Zhao JX, Zhang LB, Duan XN, Liu YH. Analysis of risk factors of surgical site infections in breast cancer. Chin Med J (Engl). 2010 Mar 5;123(5):559-62.

  PMID: 20367981 BACKGROUND

• Vilar-Compte D, Rosales S, Hernandez-Mello N, Maafs E, Volkow P. Surveillance, control, and prevention of surgical site infections in breast cancer surgery: a 5-year experience. Am J Infect Control. 2009 Oct;37(8):674-9. doi: 10.1016/j.ajic.2009.02.010. Epub 2009 Jun 24.

  PMID: 19556033 BACKGROUND

• Teija-Kaisa A, Eija M, Marja S, Outi L. Risk factors for surgical site infection in breast surgery. J Clin Nurs. 2013 Apr;22(7-8):948-57. doi: 10.1111/jocn.12009. Epub 2012 Nov 2.

  PMID: 23121264 BACKGROUND

• Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013 Oct 20;2013(10):CD006823. doi: 10.1002/14651858.CD006823.pub2.

  PMID: 24158902 BACKGROUND

• Rotstein C, Ferguson R, Cummings KM, Piedmonte MR, Lucey J, Banish A. Determinants of clean surgical wound infections for breast procedures at an oncology center. Infect Control Hosp Epidemiol. 1992 Apr;13(4):207-14. doi: 10.1086/646511.

  PMID: 1593101 BACKGROUND

• Rey JE, Gardner SM, Cushing RD. Determinants of surgical site infection after breast biopsy. Am J Infect Control. 2005 Mar;33(2):126-9. doi: 10.1016/j.ajic.2004.05.004.

  PMID: 15761414 BACKGROUND

• Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.

  PMID: 23461695 BACKGROUND

• Hedrick TL, Smith PW, Gazoni LM, Sawyer RG. The appropriate use of antibiotics in surgery: a review of surgical infections. Curr Probl Surg. 2007 Oct;44(10):635-75. doi: 10.1067/j.cpsurg.2007.06.006. No abstract available.

  PMID: 18021817 BACKGROUND

• Edwards BL, Stukenborg GJ, Brenin DR, Schroen AT. Use of prophylactic postoperative antibiotics during surgical drain presence following mastectomy. Ann Surg Oncol. 2014 Oct;21(10):3249-55. doi: 10.1245/s10434-014-3960-7. Epub 2014 Aug 20.

  PMID: 25138078 BACKGROUND

• Wilcox MH, Mooney L, Bendall R, Settle CD, Fawley WN. A case-control study of community-associated Clostridium difficile infection. J Antimicrob Chemother. 2008 Aug;62(2):388-96. doi: 10.1093/jac/dkn163. Epub 2008 Apr 22.

  PMID: 18434341 BACKGROUND

• Wilcox MH, Chalmers JD, Nord CE, Freeman J, Bouza E. Role of cephalosporins in the era of Clostridium difficile infection. J Antimicrob Chemother. 2017 Jan;72(1):1-18. doi: 10.1093/jac/dkw385. Epub 2016 Sep 22.

  PMID: 27659735 BACKGROUND

• Thomas C, Stevenson M, Riley TV. Antibiotics and hospital-acquired Clostridium difficile-associated diarrhoea: a systematic review. J Antimicrob Chemother. 2003 Jun;51(6):1339-50. doi: 10.1093/jac/dkg254. Epub 2003 May 13.

  PMID: 12746372 BACKGROUND

• Sattar AK, Zahid N, Shahzad H, Soomro R, Saleem O, Mahmood SF. Impact of duration of antibiotic prophylaxis on rates of surgical site infection (SSI) in patients undergoing mastectomy without immediate reconstruction, comparing a single prophylactic dose versus continued antibiotic prophylaxis postoperatively: a multicentre, double-blinded randomised control trial protocol. BMJ Open. 2021 Jul 9;11(7):e049572. doi: 10.1136/bmjopen-2021-049572.

  PMID: 34244280 DERIVED

Related Links

• An Updated Meta-Analysis on the Effectiveness of Preoperative Prophylactic Antibiotics in Patients Undergoing Breast Surgical Procedures
• National Practice Patterns in Preoperative and Postoperative Antibiotic Prophylaxis in Breast Procedures Requiring Drains: Survey of the American Society of Breast Surgeons

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Abida K. Sattar, MD, FACS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abida K. Sattar, MD, FACS

CONTACT

+92 345 8298088; aksattar@hotmail.com; abida.sattar@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Section Head

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)