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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Showering 48 hours after Surgery | Experimental | Group 1 will be allowed to shower 48 hours after surgery with drain tubes still in place. |
|
| Showering after drain tubes are removed | No Intervention | Group 2 will not be allowed to shower until drain tubes are removed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Showering 48 hours after surgery | Other | The main intervention is allowing patients to shower 48 hours after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
The study will involved patient's undergoing breast reconstruction following mastectomy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35505721 | Background | 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. | |
| 27464530 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2022 | Apr 21, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2022 | Apr 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
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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.
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The study is unblinded.
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| 15927829 | 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. |
| 26914348 | 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. |
| D005159 |
| Health Care Facilities Workforce and Services |