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NCT02395614 · ClinicalTrials.gov registry record · NA

Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
88
Enrollment target

NCT02395614: Completed NA study, sponsored by Vanderbilt University Medical Center.

NCT02395614 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02395614, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
88 participants
Enrollment target

Study Summary

The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.

Primary Outcome

At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of SSI (cellulitis, purulent drainage). SSI was defined as any instance where antibiotics were restarted or where erythema, cellulitis, warmth, purulent drainage, or fever occurred. SSI was further classified in 3 categories: minor when requiring oral antibiotics, major when requiring inpatient intravenous antibiotics or operative washout, and finally, explantation.

Interventions

  • DRUG Chlorhexidine irrigation
  • DRUG triple antibiotic irrigation

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2015-12
Est. Completion 2020-12
Phase NA

What the finished NCT02395614 record still lists

NCT02395614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Chlorhexidine irrigation is the first listed.

NCT02395614 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02395614 about?

NCT02395614 is a clinical study titled "Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation". The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction. Each patient w...

What is the current status of trial NCT02395614?

This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2015-12. Estimated completion is 2020-12.

What interventions are being tested in trial NCT02395614?

The interventions under investigation include: Chlorhexidine irrigation (DRUG), triple antibiotic irrigation (DRUG).

Who is sponsoring clinical trial NCT02395614?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02395614's enrollment target sits among peer trials

88 972nd of 2000 higher than 1,027 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT02395614, the US trial registry maintained by the National Library of Medicine. NCT02395614 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.