CompletedPhase 2

Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

United States110 participantsStarted 2011-05

Plain-language summary

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females or males age 18-90 able to give informed consent * Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction * May have either malignant or benign breast condition Exclusion Criteria: * Antibiotic use in the fourteen days prior to surgical date * Undergoing unilateral tissue expander reconstruction * Documented allergy to chlorhexidine gluconate * Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease) * Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin * Pregnant women * Vulnerable subjects - prisoners, institutionalized individuals * Non-English speaking patients without adequate interpreter assistance

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week

Timeframe: Approximately 1 week after surgery

Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week

Timeframe: Approximately 1 week after surgery

Trial details

NCT IDNCT01286168

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2014-10-13

View on ClinicalTrials.gov More Nonmalignant Breast Conditions trials