Status:
COMPLETED
Evaluation of SOMAVAC 100 Sustained Vacuum System
Lead Sponsor:
University of Tennessee
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Brief Summary
The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.
Detailed Description
Participants will undergo a screening that includes medical history review. Once screening is complete, participants will undergo immediate breast reconstruction per the surgeon's typical protocol. Su...
Eligibility Criteria
Inclusion
- Aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant
- Capable of providing informed consent
- Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
Exclusion
- Reconstruction is not post-mastectomy
- Pregnant or lactating females
- Patients needing more than 2 drains per breast
- Patients on steroids or other immune modulators known to impact healing
- Patients who are likely to not complete the study
- Patient who, in the opinion of the investigator, are unlikely to comply with the protocol
- Patients who have participated in this trial previously and who were withdrawn
- Patients with known allergies to contacting materials (i.e. latex, metal, etc.)
- Patients who received neoadjuvant chemotherapy or radiotherapy within the last 6 months
- Has any medical condition such as obesity (BMI\>40), uncontrolled diabetes (HbA1c\>7%) and/or immunosuppression.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04845256
Start Date
May 1 2021
End Date
October 30 2022
Last Update
February 13 2023
Active Locations (1)
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1
Plastic Surgery Group
Chattanooga, Tennessee, United States, 37402