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NCT01286168 · ClinicalTrials.gov registry record · Phase 2

Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

A Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
110
Enrollment target
2
Study locations

NCT01286168: Completed Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions, sponsored by Mayo Clinic.

NCT01286168 is a Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions that has completed, run by Mayo Clinic. The registered enrollment target is 110 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01286168, a Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
110 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.

Interventions

  • PROCEDURE Control
  • DEVICE Sodium hypochlorite (Dakin's Solution)
  • DEVICE Chlorhexidine gluconate disk
  • DEVICE Occlusive Adhesive Dressing

Study Locations (2)

California

  • UCSF - San Francisco

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2011-05
Est. Completion 2013-11
Phase Phase 2
Mayo Clinic

2,844 total trials

What the finished NCT01286168 record still lists

NCT01286168 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Control is the first listed.

NCT01286168 reports a single indexed study location in California, Minnesota.

Frequently Asked Questions

What is clinical trial NCT01286168 about?

NCT01286168 is a clinical study titled "Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction". 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 so...

What is the current status of trial NCT01286168?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2011-05. Estimated completion is 2013-11.

What conditions does trial NCT01286168 study?

This clinical trial studies the following conditions: Breast Cancer, Nonmalignant Breast Conditions.

What interventions are being tested in trial NCT01286168?

The interventions under investigation include: Control (PROCEDURE), Sodium hypochlorite (Dakin's Solution) (DEVICE), Chlorhexidine gluconate disk (DEVICE), Occlusive Adhesive Dressing (DEVICE).

Who is sponsoring clinical trial NCT01286168?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01286168 being conducted?

This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01286168's enrollment target sits among peer trials

110 536th of 1224 higher than 684 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01286168, the US trial registry maintained by the National Library of Medicine. NCT01286168 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.