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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
No Placebo-Only Group
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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.
The effects of acellular dermal matrix in expander-implant breast reconstruction after total skin-sparing mastectomy: results of a prospective practice improvement study.
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,892 Total Patients Enrolled
Jing Zhang, MDPrincipal InvestigatorOttawa Hospital Research Institute
2 Previous Clinical Trials
550 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have immediate breast reconstruction due to medical reasons.You have a history of smoking.Women with very large or sagging breasts are not eligible for the study due to a higher risk of complications after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Subpectoral implant placement
- Group 2: Prepectoral implant placement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.