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Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

NCT03195322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-12-16

No results posted yet for this study

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.

Conditions

  • Postoperative Pain
  • Postoperative Nausea and Vomiting
  • Quality of Life
  • Breast Cancer
  • Breast Prosthesis; Pain

Interventions

PROCEDURE

Pre-pectoral Tissue Expander

All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.

Sponsors & Collaborators

Principal Investigators

  • Gedge D Rosson, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-11-30
Completion
2021-12-10

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03195322 on ClinicalTrials.gov