At a glance
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The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot
In Brief
A clinical study evaluating Pre-pectoral Tissue Expander for Postoperative Pain and 4 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Primary Objective: • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Secondary Objectives: * To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement * To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. * To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement. * To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. * To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant. * To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant. * To describe the patient's final assessment of pre-pectoral reconstruction from free-form text. Tertiary Objectives: • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.
Study Details
Timeline
Interventions
All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.