What side effects are associated with this type of intervention?

Common treatments for breast cancer, including those involving Acellular Dermal Matrix (ADM)-Assisted Implant-Based Breast Reconstruction, have various side effects. Surgery can lead to pain, infection, and lymphedema. Radiation therapy may cause skin irritation, fatigue, and changes in breast tissue. Chemotherapy is associated with nausea, hair loss, fatigue, and increased infection risk. Hormone therapy can result in hot flashes, bone thinning, and cardiovascular issues. ADM-assisted reconstruction specifically may involve complications such as infection, implant rippling, and the need for additional fat grafting.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of chemotherapeutic agents, hormone therapies, and targeted therapies. While specific treatments that provide structural support similar to Acellular Dermal Matrix (ADM)-Assisted Implant-Based Breast Reconstruction are not detailed, common FDA-approved drugs for breast cancer include doxorubicin, paclitaxel, and trastuzumab. These treatments focus on reducing tumor size and preventing cancer spread, which can be crucial in preparing for surgical interventions such as implant-based reconstruction.

What other types of research exist?

Promising novel alternatives to ADM-assisted implant-based breast reconstruction for breast cancer patients include: <ol> <li>Prepectoral Implant Placement: This technique places the implant above the pectoral muscle, potentially reducing postoperative pain and muscle dysfunction.</li> <li></li> </ol> Autologous Fat Grafting: This method uses the patient's own fat to reconstruct the breast, offering a natural feel and appearance. 3. Vascularized Lymph Node Transfer: This technique not only reconstructs the breast but also addresses lymphedema by transferring lymph nodes along with the tissue. 4. 3D-Printed Custom Implants: These implants are tailored to the patient's anatomy, providing a personalized fit and potentially better aesthetic outcomes.

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Procedure

Pre-pectoral vs Sub-pectoral Implant Placement for Breast Reconstruction

N/A

Waitlist Available

Led By Jing Zhang, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial compares two methods of breast implant placement after mastectomy to see which causes less pain and has better outcomes. It targets women having breast reconstruction and uses a special supportive tissue in both methods.

Who is the study for?

This trial is for women aged 20-80 who are undergoing mastectomy due to breast cancer or as a preventive measure and can consent to the study. It's not for those with immediate reconstruction contraindications, smokers, BMI over 40, prior chest radiation, or large breast size/grade III ptosis.

What is being tested?

The study compares two techniques of implant-based breast reconstruction after mastectomy: one places the implant above the chest muscle (prepectoral), while the other places it under (subpectoral). The goal is to assess post-surgery pain, complications, and patient satisfaction.

What are the potential side effects?

Potential side effects include early postoperative pain and possible visible rippling of implants with prepectoral placement. There may also be a need for additional fat grafting procedures. Both methods aim to have similar safety profiles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative Pain and 24-hour narcotic consumption

Secondary study objectives

BREAST-Q© Post-operative

BREAST-Q© Pre-operative scale

Mastectomy flap necrosis

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prepectoral implant placementExperimental Treatment1 Intervention

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.

Group II: Subpectoral implant placementActive Control1 Intervention

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments encompass a variety of mechanisms aimed at eradicating cancer cells and preventing recurrence. Surgery, such as mastectomy, physically removes the tumor and affected tissues. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while radiation therapy employs high-energy rays to destroy cancerous tissue. Targeted therapies, including hormone therapy and HER2 inhibitors, block specific molecules involved in cancer growth. In the context of Acellular Dermal Matrix (ADM)-Assisted Implant-Based Breast Reconstruction, ADM provides structural support and integrates with host tissue, facilitating implant placement and improving cosmetic outcomes post-mastectomy. This matters for breast cancer patients as it not only aims to treat the cancer but also addresses the physical and psychological impacts of breast loss, enhancing overall quality of life.

The effects of acellular dermal matrix in expander-implant breast reconstruction after total skin-sparing mastectomy: results of a prospective practice improvement study.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

572 Previous Clinical Trials

2,788,966 Total Patients Enrolled

34 Trials studying Breast Cancer

5,214 Patients Enrolled for Breast Cancer

Jing Zhang, MDPrincipal InvestigatorOttawa Hospital Research Institute

2 Previous Clinical Trials

550 Total Patients Enrolled

Media Library

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03959709 — N/A

Breast Cancer Research Study Groups: Subpectoral implant placement, Prepectoral implant placement

Breast Cancer Clinical Trial 2023: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement Highlights & Side Effects. Trial Name: NCT03959709 — N/A

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03959709 — N/A

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