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Complications; Breast Prosthesis, Infection or Inflammation | Antibiotics and Tissue Expanders in Breast Reconstruction

Complications; Breast Prosthesis, Infection or Inflammation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Complications; Breast Prosthesis, Infection or Inflammation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

antibiotic7 days of preventive antibiotics after surgery

No antibioticNo preventive postoperative antibiotics

Study Status

Withdrawn

Start Date: June 2016

Completed Date: December 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Surgical site infection

Secondary Outcome: Surgical site infection requiring implant/expander removal

Study sponsors, principal investigator, and references

Principal Investigator: Grant W Carlson, MD

Lead Sponsor: Emory University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01899690

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