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

NCT05846438 | Recruiting

• 1 other identifier: 2092673
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections; Quality of Life

Outcome Measures

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.

  90 days

Secondary Outcomes (1)

• Quality of Life Survey

  90 days

Study Arms (2)

Showering 48 hours after Surgery

EXPERIMENTAL

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

Other: Showering 48 hours after surgery

Showering after drain tubes are removed

NO INTERVENTION

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

Interventions

Showering 48 hours after surgery OTHER

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

Showering 48 hours after Surgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: The study will involved patient's undergoing breast reconstruction following mastectomy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 35505721 BACKGROUND

• 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.

  PMID: 27464530 BACKGROUND

• 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.

  PMID: 15927829 BACKGROUND

• 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.

  PMID: 26914348 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is unblinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Plastic and Reconstructive Surgery

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: March 15, 2023
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)