Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversity of Missouri-Columbia
About this trial
The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection. The main questions it aims to answer are:
* Is there an increased risk of infection/complications with showering 48 hours after drain tubes are in place * Does showering after 48 hours with drain tubes in place affect quality of life.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
undergoing breast surgery with placement of tissue expander and drains, acceptance of protocol and procedures, age > 18
Disqualifiers
no existing wounds, previous infections related to implant device if delayed, refusal by patient
Trial design
Design model
Parallel
Treatments tested in this trial
Showering 48 hours after surgery
Other interventionThe main intervention is allowing patients to shower 48 hours after surgery
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Showering 48 hours after SurgeryExperimental treatment 1 intervention
Group B: Showering after drain tubes are removedNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Presence of Post Operative Infection
The primary outcome measure will be the presence of infection as judged by the non blinded attending surgeon within the 90 day time frame during post operative evaluations. A breast infection is defined as increased erythema, warmth, and pain at the breast or systemic symptoms such as fevers and chills. Breast infections will be treated with a course of IV antibiotics and possible tissue expander removal and breast pocket irrigation and debridement in the operating room. If the attending physician determines that an infection is present any time during the treatment period the patient will be categorized as infected.
Time frame
90 daysSecondary outcomes
1
Quality of Life Survey
Subjects will complete a survey at 90 days using a scale from 0 (strongly disagree) to 5 (strongly agree) indicating how showering or not showering with drain tubes in place affected their quality of life.
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov