Clinical trial NCT04874402: Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
Official title: Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Reconstruction Following Mastectomy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction.

Detailed description: This is a single center, single-blinded, randomized clinical trial involving adult women undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction. The aim is to generate high quality evidence before establishing the prepectoral technique as routine care. A favorable safety and patient satisfaction profile will bring high quality evidence supporting the adoption of a technique that has shown similar complication rates while eliminating animation deformity and its associated pain and discomfort in retrospective and non-randomized studies.

The mastectomy flap perfusion will be assessed clinically and using SPY fluorescence imaging. Immediately following mastectomy, participants will be randomized to one of two treatment arms.

Group A will be composed of participants who will undergo prepectoral reconstruction with Acellular Dermal Matrix (ADM) by means of the anterior tenting technique. In this technique, two sheets of contour, fenestrated ADM sutured together are trimmed in accordance with the measurement of the expander/implant and fixed to the pectoralis major muscle covering the entire anterior surface of the device

Group B (current standard of care (SOC)) will be composed of participants who will undergo partial subpectoral reconstruction with ADM by means of the sling technique. In this technique the leading edge of the pectoral muscle is elevated and a subpectoral pocket is fashioned. The lower medial origin muscle fibers are released for anatomical expander seating. An ADM sling is sutured from the leading edge of the pectoralis muscle to the inframammary fold (over the expander) and laterally to close the expander pocket.

Eligibility criteria: Inclusion Criteria:

- Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction

Exclusion Criteria:

* Active use of any tobacco products
* Uncontrolled diabetes defined by HbA1c greater than 7.5%
* Class II obesity or higher defined by a body mass index equal or greater than 35 kg/m2
* History of radiation to the affect breast or chest
* Immunocompromised patients
* Clinical evidence of significant mastectomy flap ischemia prior to the initiation of the reconstructive procedure

Primary outcomes:
measure: Patient satisfaction as measured by BREAST-Q-scores
timeFrame: Preoperatively
measure: Patient satisfaction as measured by BREAST-Q-scores
timeFrame: postoperative day 90 +/-30 days
Secondary outcomes:
measure: Overall complication rates
timeFrame: Preoperatively
measure: Overall complication rates
timeFrame: Postoperative day 1
measure: Overall complication rates
timeFrame: Postoperative day 7 +/-7 days
measure: Overall complication rates
timeFrame: Postoperative day 14 +/-7 days
measure: Overall complication rates
timeFrame: postoperative day 21 +/-7 days
measure: Overall complication rates
timeFrame: postoperative day 90 +/-30 days
measure: Specific complication rates
timeFrame: Preoperatively
measure: Specific complication rates
timeFrame: Postoperative day 1
measure: Specific complication rates
timeFrame: Postoperative day 7 +/-7 days
measure: Specific complication rates
timeFrame: Postoperative day 14 +/-7 days
measure: Specific complication rates
timeFrame: postoperative day 21 +/-7 days
measure: Postoperative pain intensity
timeFrame: Postoperative day 1
measure: Postoperative pain intensity
timeFrame: Postoperative day 7 +/-7 days
measure: Postoperative pain intensity
timeFrame: Postoperative day 14 +/-7 days
measure: Postoperative pain intensity
timeFrame: postoperative day 21 +/-7 days
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida, Case Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida, Case Comprehensive Cancer Center
name: Amir Ghaznavi, MD
role: PRINCIPAL_INVESTIGATOR
References: