N/A
N=88
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02395614 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Surgical Site Infection — 7; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chlorhexidine irrigation (Drug); triple antibiotic irrigation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgical Site Infection |
7; 4 | — |
| SECONDARY Number of Participants With Flap Necrosis, Hematoma, and Seroma |
21; 23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- females between 18 - 81 years of age
- and are undergoing bilateral mastectomy
- and are candidates for immediate breast reconstruction with tissue expanders.
Exclusion Criteria
- females younger than 18 and older than 81 years of age;
- undergoing unilateral mastectomy and reconstruction;
- bilateral reconstruction using other techniques,
- patients allergic to one or more components of the antibiotic solution;
- allergy to CHG
Data sourced from ClinicalTrials.gov (NCT02395614). 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.