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

Primary Purpose

Infections, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Showering 48 hours after surgery
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infections

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Showering 48 hours after Surgery

Showering after drain tubes are removed

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 5, 2023
Last Updated
April 26, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05846438
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will 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.
Masking
None (Open Label)
Masking Description
The study is unblinded.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Showering 48 hours after Surgery
Arm Type
Experimental
Arm Description
Group 1 will be allowed to shower 48 hours after surgery with drain tubes still in place.
Arm Title
Showering after drain tubes are removed
Arm Type
No Intervention
Arm Description
Group 2 will not be allowed to shower until drain tubes are removed.
Intervention Type
Other
Intervention Name(s)
Showering 48 hours after surgery
Intervention Description
Our main intervention is allowing patients to shower 48 hours after surgery
Primary Outcome Measure Information:
Title
Presence of Post Operative Infection
Description
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 days
Secondary Outcome Measure Information:
Title
Quality of Life Survey
Description
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 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study will involved patient's undergoing breast reconstruction following mastectomy.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Dean
Phone
573-882-2277
Email
deanam@health.missour.ed
First Name & Middle Initial & Last Name & Degree
Stephen Colbert, MD
First Name & Middle Initial & Last Name & Degree
Sarah Langsdon, MD
First Name & Middle Initial & Last Name & Degree
Tindal Mclaurin, MD
First Name & Middle Initial & Last Name & Degree
Ameya Chumble, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35505721
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.
Results Reference
background
PubMed Identifier
27464530
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.
Results Reference
background
PubMed Identifier
15927829
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.
Results Reference
background
PubMed Identifier
26914348
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.
Results Reference
background

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

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