Antibiotics and Tissue Expanders in Breast Reconstruction
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ClinicalTrials.gov Identifier: NCT01899690 |
Recruitment Status
:
Withdrawn
(The study was withdrawn prior to IRB approval.)
First Posted
: July 15, 2013
Last Update Posted
: February 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Complications; Breast Prosthesis, Infection or Inflammation | Drug: antibiotic | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Impact of Prophylactic Perioperative Antibiotic Administration on Surgical Site Infections Following Implant-based Breast Reconstruction. |
Estimated Study Start Date : | June 2016 |
Estimated Primary Completion Date : | August 2017 |
Estimated Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: antibiotic
7 days of preventive antibiotics after surgery
|
Drug: antibiotic
Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics.
Other Names:
|
No Intervention: No antibiotic
No preventive postoperative antibiotics
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- Surgical site infection [ Time Frame: one year ]Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction
- Surgical site infection requiring implant/expander removal [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899690
Principal Investigator: | Grant W Carlson, MD | Emory University |
Responsible Party: | Grant Carlson, Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT01899690 History of Changes |
Other Study ID Numbers: |
IRB00063849 |
First Posted: | July 15, 2013 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
Keywords provided by Grant Carlson, Emory University:
breast reconstruction cancer expander antibiotics infection |
surgical site infection surgery oncology plastic surgery |
Additional relevant MeSH terms:
Infection Communicable Diseases Inflammation Surgical Wound Infection Pathologic Processes Wound Infection |
Postoperative Complications Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |