Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement

NCT06783179 | Recruiting

• 2 other identifiers: 24-006876NCI-2024-10631
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. A new model of delivering patient care was created at the Mayo Clinic Florida coined the "Care Hotel." This is a temporal, voluntary accommodation that offers patients a comfortable environment to receive nursing care before or after hospital treatment with in-person daytime monitoring and 24-hour virtual tele-monitoring in a hotel setting. This study evaluates post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complications

  Recorded as incidence of hematoma, infection, readmission, and/or reoperation within 30 days of initial procedure.

  Up to 30 days

Secondary Outcomes (1)

• Patient satisfaction

  Up to 30 days

Study Arms (1)

Observational

Patients have their medical records reviewed and may complete a survey on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis.

You may qualify if:

• Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.

You may not qualify if:

• Younger than 18 years old.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brian D. Rinker, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Maurician Buchanan

CONTACT

Buchanan.Mauricia@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 16, 2027
• Study Completion (Estimated): December 16, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)