Tissue Expansion in Breast Reconstruction Without Drains

Completed

• Conditions: Breast Implant; Complications; Breast Cancer; Hereditary Breast and Ovarian Cancer Syndrome
• Interventions: Device: Insertion of Tissue Expander with Fluid Reservoir

• Registration Number: NCT03784859
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.

Detailed Description

Patients electing to have staged, implant-based, bilateral breast reconstruction at the time of mastectomy (for either cancer or cancer prevention) will undergo a standardized subpectoral tissue expander placement (using the Sientra AlloX2 dual-port device) on each side of the chest with a single piece of acellular dermal matrix (ADM). A single drain in the subcutaneous pocket of each breast will be used and removed on the first post-operative day. Patients will be admitted for overnight observation in the hospital. Each post-operative day fluid will be aspirated from each reservoir port using a standard sterile technique, and the volume recorded. After discharge, patients will be seen in the office within one week of discharge and fluid aspirated from each expander using the reservoir ports, and the volume shall be recorded. The aspiration will be repeated weekly until expansion is completed and/or the amount of fluid aspirated is less than 10 cc.

Patients will be asked to complete a 7 item multiple-choice questionnaire regarding their attitudes about their breast reconstruction, first at completion of tissue expansion and finally at their first follow-up visit following placement of permanent breast implants.

This study utilizes FDA 510k-classified devices that allow removal of fluid without drains, in lieu of more conventional expanders, allowing for the avoidance of prolonged drain usage.

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Study Start: 2019-02-25
• Primary Completion: 2020-07-13
• Status Verified: 2020-10
• Study Completion: 2020-10-02
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• Patients undergoing bilateral breast reconstruction following mastectomy (performed to treat stage I-III breast cancer or for prevention of breast cancer).
• Non-smokers
• BMI less than 31
• No other significant surgical risk factors that make elective use of implants dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)

Exclusion Criteria

• Unilateral mastectomy patients
• Current smokers
• Those with bleeding dyscrasias or clotting disorders
• Those who have had or will have a full axillary lymph node dissection
• Cases where there is an unusually high degree of bleeding intra-operatively (more than 150 cc)
• Those with a BMI greater than 30
• Those with history of prior breast surgery (aside from lumpectomy or needle biopsy)
• Those with a history of prior breast radiation
• Those with stage IV or unresectable breast cancer
• Significant surgical risk factors that make elective use of implants dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients in study	Insertion of Tissue Expander with Fluid Reservoir	5 consecutive patients with breast cancer or a breast cancer-causing gene that elect to undergo bilateral breast reconstruction will be Insertion of Tissue Expander with Fluid Reservoir as the first stage of reconstruction. Post-surgical care will be similar as patients with conventional expanders, except that during office visits, fluid will be transcutaneously aspirated from the fluid reservoir on each side.

Primary Outcome Measures

Name	Time	Method
Number of patients with successful breast reconstruction using reservoir-expanders	4-6 months	The number of patients that successfully complete two stage implant-based breast reconstruction with fluid-reservoir tissue expanders and early drain removal. An outcome failure would be if the expander required removal due to uncontrolled seroma, infection or other factor that prevents a successful implant-based reconstruction.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States