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

Completed · Not applicable

Conditions studied: Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life, Breast Cancer, Breast Prosthesis; Pain

In brief

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.

Key facts

Study ID

NCT03195322

Run by

Johns Hopkins University

People needed

20

Starts

2017-10-01

Expected to finish

2021-12-10

Last updated by the study team

2021-12-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be women, aged 18-75 years.
• Choose bilateral mastectomy (therapeutic or prophylactic) followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
• Have no inflammatory breast cancers.
• Be aware of the nature of her malignancy.
• Understand the study purpose, requirements, and risks.
• Be able and willing to give informed consent.

You may not qualify if…

• Plan to undergo final reconstruction with autologous material.
• Allergies to gentamicin, cefoxitin, lincomycin, vancomycin, or polymixin (antibiotics used in the pre-treatment of AlloDerm®).
• Active connective tissue disease.
• Current smokers.
• History of, or plan to undergo irradiation of the breasts.

Where it is running

• The Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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