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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

Study Summary

This trial is a comparative, multicenter, prospective, single-blinded study which will include 100 patients.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative Pain and 24-hour narcotic consumption

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,635 Total Patients Enrolled

34 Trials studying Breast Cancer

5,205 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: Prepectoral implant placement, Subpectoral 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people aged under 55 permitted to join this research study?

"This experiment is looking for volunteers between the ages of 20 and 80."

Answered by AI

Are there any spaces open for prospective participants in this trial?

"Absolutely. According to the details provided by clinicaltrials.gov, this medical investigation is still searching for participants as of April 26th 2022; it was initially posted on August 22nd 2019. For now, 56 individuals will be admitted from a single trial site."

Answered by AI

How many participants are included in the scope of this research?

"Affirmative. Clinicaltrials.gov attests that this research project, which was initially advertised on August 22nd 2019, is actively looking for enrollees. 56 participants are required from a single site to complete the trial."

Answered by AI

Are there any eligibility criteria that I must satisfy in order to join this clinical experiment?

"For this trial, 56 individuals with a history of mastectomy are necessary. Specifically, the population should consist of females aged between 20 and 80 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction

2019. "Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03959709.