Phase 2 N=104 Randomized Single-blind Prevention

Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Nonmalignant Breast Conditions · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01286168 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week — 10; 21 participants — p=0.02

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sodium hypochlorite (Dakin's Solution) (Device); Chlorhexidine gluconate disk (Device); Control (Procedure); Occlusive Adhesive Dressing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week	10; 21	0.02 sig
PRIMARY Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week	11; 25	0.02 sig
SECONDARY Number of Subjects With Drain Tubing Colonization at Removal	0; 6	0.03 sig
SECONDARY Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal	14; 28	0.003 sig
SECONDARY Number of Subjects With Surgical Site Infection Within 30 Days	0; 4	0.13
SECONDARY Number of Subjects With Surgical Site Infection Within 1 Year	3; 6	0.45
SECONDARY Per Drain Analysis: Drain Tubing Colonization at Removal	0; 6	0.004 sig
SECONDARY Per Drain Analysis: Drain Bulb Fluid Colonization at Removal	14; 33	0.003 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01286168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.