Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.

University of Missouri (MU)

Status: Enrolling

Conditions: Quality of Life; Infections

Treatments: Other: Showering 48 hours after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05846438

2092673

Details and patient eligibility

About

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.

Full description

SSI (soft tissue infection) is an aggravating risk specifically associated with implants. Breast reconstruction quotes infection rates anywhere from 1-35% while cosmetic augmentations quote rates around 1.5%. Usually, the causative organisms are skin flora like Staph aureus and Staph epidermidis. Occasionally mycobacterium and other atypical bacterium are isolated more commonly in the immunocompromised. Despite perioperative antibiotics, SSI is still a prevalent complication increasing total expenditure of patients and hospital systems upwards of $4000/patient in reoperation fees and hospital stay costs. Skin prep and antibiotics in the preoperative phase is very important to the sterile technique and decreasing risk of infection by decreasing bacterial load at the time of incision and surgery. However, postoperative care and interventions are less strictly evaluated and defined. Currently, there is no standard of care in regards to showering post operatively with JP (Jackson-Pratt) drains in place. Timing of showering is ultimately based on surgeon preference. In practice, the investigators routinely have had patients wait to shower until the JP drains are removed. The investigators hypothesize that showering daily, even with drains in place, will not increase rates of infection in breast reconstruction and perhaps improve quality of life during first stage. This study is prospective with participants randomized to either shower daily after 48hrs or standard of care and shower after drains removed. The participants will be asked to fill out a quality of life survey 90 days after enrollment. The patients will also be monitored for signs of infection for 90 days.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• undergoing breast surgery with placement of tissue expander and drains, acceptance of protocol and procedures, age > 18

Exclusion criteria

• no existing wounds, previous infections related to implant device if delayed, refusal by patient

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Showering 48 hours after Surgery

Experimental group

Description:

Group 1 will be allowed to shower 48 hours after surgery with drain tubes still in place.

Treatment:

Other: Showering 48 hours after surgery

Showering after drain tubes are removed

No Intervention group

Description:

Group 2 will not be allowed to shower until drain tubes are removed.