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临床试验/NCT05846438
NCT05846438招募中不适用

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

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Presence of Post Operative Infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

The study is unblinded.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Showering 48 hours after Surgery

Experimental

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

干预措施: Showering 48 hours after surgery (Other)

Showering after drain tubes are removed

No Intervention

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

结局指标

主要结局

Presence of Post Operative Infection

时间窗: 90 days

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.

次要结局

  • Quality of Life Survey(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Colbert

Division Chief of Plastic and Reconstructive Surgery

University of Missouri-Columbia

研究点 (2)

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