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Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

NCT01286168 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2014-12-19

Study results available
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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.

Conditions

Interventions

DEVICE

Sodium hypochlorite (Dakin's Solution)

10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day

DEVICE

Chlorhexidine gluconate disk

Apply one chlorhexidine disk to the intervention drain site(s) and change every three days

PROCEDURE

Control

Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.

DEVICE

Occlusive Adhesive Dressing

A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.

Sponsors & Collaborators

Principal Investigators

  • Amy C Degnim, M.D. · Mayo Clinic, Rochester, MN

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286168 on ClinicalTrials.gov