Antibiotics and Tissue Expanders in Breast Reconstruction

NCT01899690 | Withdrawn Phase 4

• 1 other identifier: IRB00063849
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction. The investigators hypothesize that use of prophylactic antibiotics after breast reconstruction does not reduce surgical site infections.

Conditions

Complications; Breast Prosthesis, Infection or Inflammation

Keywords

breast reconstruction; cancer; expander; antibiotics; infection; surgical site infection; surgery; oncology; plastic surgery

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction

  one year

Secondary Outcomes (1)

• Surgical site infection requiring implant/expander removal

  one year

Study Arms (2)

antibiotic

EXPERIMENTAL

7 days of preventive antibiotics after surgery

Drug: antibiotic

No antibiotic

NO INTERVENTION

No preventive postoperative antibiotics

Interventions

antibiotic DRUG

Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics.

Also known as: cephalexin (Keflex), clindamycin, bactrim, (in order of choice pending relevant allergies)

antibiotic

Eligibility Criteria

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

You may qualify if:

• Patients in whom implant-based breast reconstruction is selected based on clinician recommendation, patient agreement, and mutual consensus.
• Ability to understand the purposes and risks of the study and willingly give standard written informed consent for treatment established by Emory University Hospital and affiliates.

You may not qualify if:

• Pregnancy
• Incarceration
• Non-implant based reconstructive plan
• Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Infections; Inflammation; Neoplasms; Surgical Wound Infection

Interventions

Anti-Bacterial Agents; Cephalexin; Clindamycin; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 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; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Trimethoprim; Pyrimidines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Grant W Carlson, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 15, 2013
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02