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

NCT ID: NCT05846438

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-03-15

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.

Conditions

Infections; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Showering 48 hours after Surgery

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

Group Type: EXPERIMENTAL

Showering 48 hours after surgery

Intervention Type: OTHER

The main intervention is allowing patients to shower 48 hours after surgery

Showering after drain tubes are removed

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Showering 48 hours after surgery

The main intervention is allowing patients to shower 48 hours after surgery

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Stephen Colbert

Division Chief of Plastic and Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Missouri

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Amelia Dean

Role: primary

deanam@health.missour.ed

573-882-2277

References

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.

Reference Type: BACKGROUND

PMID: 35505721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27464530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15927829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26914348 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2092673

Identifier Type: -

Identifier Source: org_study_id