Postoperative Antibiotics Following Primary and Secondary Breast Augmentation

NCT04834310 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: UCLA PRS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative antibiotics are routinely used for implant-based breast augmentation at the investigators' institution. From 2017-2019, the investigators' institution has conducted approximately 270 primary and secondary breast augmentation procedures. Current plastic surgery literature does not provide recommendations for antibiotic prophylaxis following implant-based breast procedures. Despite controversy surrounding their utility during the postoperative course, postoperative antibiotics have become commonplace for many plastic surgeons. To date, strong scientific evidence supporting this practice is minimal and based largely on anecdotal evidence and limited studies, including poorly controlled retrospective and non-blinded prospective series. The goal of this study is to conduct a prospective randomized trial to assess whether extended antibiotic prophylaxis is necessary to prevent infection and long-term complications (e.g. capsular contracture) in patients undergoing augmentation mammoplasty with implants. The investigators' anticipate that extended antibiotic prophylaxis is not required. The rationale for discontinuing postoperative antibiotics is based on the following: (1) a single dose of preoperative intravenous antibiotics has been demonstrated to be sufficient prophylaxis for most breast surgeries and (2) there are patient safety concerns associated with prolonged antimicrobial use such as the development of resistant bacterial strains and clostridium-related infections. Concrete evidence that extended antibiotic prophylaxis is not required would encourage plastic surgeons to practice better antibiotic stewardship and help stymie the rise of drug-resistant organisms.

Conditions

Surgical Site Infection; Capsular Contracture Associated With Breast Implant; Antibiotic Resistant Infection; Antibiotic Side Effect

Outcome Measures

Primary Outcomes (1)

• Number of participants with surgical site infection

  Surgical site infections will be determined by the surgeon however will be defined by the presence of the following signs and symptoms: fevers, purulent drainage, pain, tenderness, localized edema, heat, erythema, positive wound cultures, and leukocytosis.

  365 days following surgery

Secondary Outcomes (6)

• Number of participants with hematoma

  365 days following surgery

• Number of participants with seroma

  365 days following surgery

• Number of participants with wound dehiscence

  365 days following surgery

• Number of participants with implant loss

  365 days following surgery

• Number of participants with antibiotic-related complications

  365 days following surgery

Other Outcomes (1)

• Patient compliance

  365 days following surgery

Study Arms (2)

Intraoperative and Postoperative Antibiotics

EXPERIMENTAL

The experimental group will receive an intraoperative dose of antibiotics, which is standard protocol at our institution, followed by oral antibiotics for 5 days postoperatively.

Drug: Cefazolin; Drug: Cephalexin

Intraoperative Antibiotics and Placebo

PLACEBO COMPARATOR

The control group will receive an intraoperative dose of antibiotics, which is standard protocol at our institution, followed by a placebo for 5 days postoperatively

Drug: Cefazolin; Other: Placebo

Interventions

Cefazolin DRUG

All patients will receive an intraoperative dose of IV Cefazolin 2 g (re-dose after 4 hours) or IV Clindamycin 600mg (re-dose after 6 hours) for penicillin allergic patients.

Also known as: Ancef, Clindamycin, Cleocin

Intraoperative Antibiotics and Placebo; Intraoperative and Postoperative Antibiotics

Cephalexin DRUG

The experimental group will receive a postoperative 5-day course of Cephalexin 500 mg QID or Clindamycin 300 mg QID for penicillin allergic patients. All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy.

Also known as: Keflex, Clindamycin, Cleocin

Intraoperative and Postoperative Antibiotics

Placebo OTHER

The placebo group will receive a postoperative 5-day course of placebos (sugar capsules). All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy.

Intraoperative Antibiotics and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 year or older
• Participants undergoing primary breast augmentation with subglandular or submuscular implants
• Participants undergoing breast augmentation-mastopexy with subglandular or submuscular implants
• Participants undergoing secondary breast augmentation with subglandular or submuscular implants (i.e. patients undergoing implant exchange secondary to capsular contracture and implant rupture)

You may not qualify if:

• Refusal or inability to obtain consent from participants
• Participants with biopsy-proven breast cancer
• Participants undergoing expander-based breast reconstruction
• Participants undergoing autologous flap breast reconstruction
• Participants with history of chest radiation
• Participants with active infection at the time of surgery
• Participants who fail to take the placebos or antibiotics provided in the study for any reason
• Participants who miss postoperative visits
• Participants who withdraw consent at any stage of the study

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (6)

• Chopra K, Gowda AU, McNichols CHL, Brown EN, Slezak S, Rasko Y. Antimicrobial Prophylaxis Practice Patterns in Breast Augmentation: A National Survey of Current Practice. Ann Plast Surg. 2017 Jun;78(6):629-632. doi: 10.1097/SAP.0000000000000942.

  PMID: 27922894 BACKGROUND

• Hardwicke JT, Bechar J, Skillman JM. Are systemic antibiotics indicated in aesthetic breast surgery? A systematic review of the literature. Plast Reconstr Surg. 2013 Jun;131(6):1395-1403. doi: 10.1097/PRS.0b013e31828bd752.

  PMID: 23416440 BACKGROUND

• Keramidas E, Lymperopoulos NS, Rodopoulou S. Is antibiotic prophylaxis in breast augmentation necessary? A prospective study. Plast Surg (Oakv). 2016 Fall;24(3):195-198. doi: 10.4172/plastic-surgery.1000976. Epub 2016 Aug 19.

  PMID: 28439510 BACKGROUND

• LeRoy J, Given KS. Wound infection in breast augmentation: the role of prophylactic perioperative antibiotics. Aesthetic Plast Surg. 1991 Fall;15(4):303-5. doi: 10.1007/BF02273877.

  PMID: 1950803 BACKGROUND

• Mirzabeigi MN, Mericli AF, Ortlip T, Tuma GA, Copit SE, Fox JW 4th, Moore JH Jr. Evaluating the role of postoperative prophylactic antibiotics in primary and secondary breast augmentation: a retrospective review. Aesthet Surg J. 2012 Jan;32(1):61-8. doi: 10.1177/1090820X11430830.

  PMID: 22231414 BACKGROUND

• Gylbert L, Asplund O, Berggren A, Jurell G, Ransjo U, Ostrup L. Preoperative antibiotics and capsular contracture in augmentation mammaplasty. Plast Reconstr Surg. 1990 Aug;86(2):260-7; discussion 268-9.

  PMID: 2195567 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Clindamycin; 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; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Karie Villanueva, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Jaco Festekjian, MD

  University of California, Los Angeles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be performed prior to surgery, and an assigned coordinator will generate group assignments. Patients and surgeons will be blinded to the study before randomization takes place. However, surgeons will have access to information following medication dispensation in case any complications arise so that the provider can carry out appropriate interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be designed as a non-inferiority trial with two parallel groups: the experimental group will receive an intraoperative dose of antibiotics followed by oral antibiotics for 5 days postoperatively (Cephalexin 500 mg QID or Clindamycin 300 mg QID, if Penicillin allergic) while the control group will receive an intraoperative dose of antibiotics (Cefazolin 1 g or 2 g, or Clindamycin 600 mg or 900 mg, if Penicillin allergic, higher doses provided if BMI \> 30 kg/m2) followed by a placebo for 5 days postoperatively.

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share