Clinical trial NCT05846438: Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.
Official title: Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infections
Quality of Life
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators have two groups of patients. Group one will be allowed to shower 48 hours after surgery. Group two will not be allowed to shower until the drains are removed.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Post Operative Infection
timeFrame: 90 days
Secondary outcomes:
measure: Quality of Life Survey
timeFrame: 90 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
citation: Ogawa H, Tahara S. Postoperative Showering for Patients With Closed Suction Drainage: A Retrospective Cohort Study of Deep Inferior Epigastric Perforator Flap Breast Reconstructions. Cureus. 2022 Mar 30;14(3):e23665. doi: 10.7759/cureus.23665. eCollection 2022 Mar.
citation: Gowda AU, Chopra K, Brown EN, Slezak S, Rasko Y. Preventing Breast Implant Contamination in Breast Reconstruction: A National Survey of Current Practice. Ann Plast Surg. 2017 Feb;78(2):153-156. doi: 10.1097/SAP.0000000000000822.
citation: Elder EE, Brandberg Y, Bjorklund T, Rylander R, Lagergren J, Jurell G, Wickman M, Sandelin K. Quality of life and patient satisfaction in breast cancer patients after immediate breast reconstruction: a prospective study. Breast. 2005 Jun;14(3):201-8. doi: 10.1016/j.breast.2004.10.008.
citation: Hanna KR, Tilt A, Holland M, Colen D, Bowen B, Stovall M, Lee A, Wang J, Drake D, Lin K, Uroskie T, Campbell CA. Reducing Infectious Complications in Implant Based Breast Reconstruction: Impact of Early Expansion and Prolonged Drain Use. Ann Plast Surg. 2016 Jun;76 Suppl 4:S312-5. doi: 10.1097/SAP.0000000000000760.