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

Overseen By Angel Arnaout, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Prior irradiation, Smoking, BMI>40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two breast reconstruction surgery methods to determine which results in less pain and better patient satisfaction. One method places the implant over the chest muscle (prepectoral), while the other places it under the muscle (subpectoral). Researchers aim to assess how these techniques affect pain, complications, and patient satisfaction. Women undergoing a mastectomy for breast cancer or as a preventive measure, and receiving immediate breast reconstruction, may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to valuable research that could enhance future breast reconstruction outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these implant placement techniques are safe for breast reconstruction?

Studies have shown that both prepectoral and subpectoral breast implant placements are similarly safe. Research on prepectoral reconstruction using acellular dermal matrix (ADM) has found low complication rates, similar to those with subpectoral placement. For example, one study reported a 6.5% rate of capsular contracture (tightening of tissue around the implant) and a 4.1% rate of implant loss, both of which are quite low.

Overall, prepectoral reconstruction is considered safe and comparable to subpectoral reconstruction. Both methods are well-tolerated by patients, with no major differences in most complications. While prepectoral placement might cause some visible rippling of the implant, it does not affect overall safety compared to subpectoral placement.

In summary, current studies suggest that both types of implant placements are safe options for breast reconstruction. They have low complication rates, making them reliable choices for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different techniques for implant placement in breast reconstruction: pre-pectoral and subpectoral. Unlike traditional subpectoral placement, which involves positioning the implant under the chest muscle, pre-pectoral placement positions the implant above the muscle. This can potentially lead to less pain and a quicker recovery since the muscle is not disturbed. Additionally, both methods use an acellular dermal matrix to support the implant, which might improve outcomes and aesthetic results. By comparing these two approaches, the trial aims to determine which method offers better recovery and satisfaction for patients.

What evidence suggests that this trial's treatments could be effective for breast reconstruction?

This trial will compare two methods of implant placement for breast reconstruction: prepectoral and subpectoral. Research has shown that placing implants over the chest muscle (prepectoral) can help avoid issues like muscle problems and implant shifting. Studies also suggest it may lead to fewer cases of capsular contracture, where the tissue around the implant tightens. However, this method might make the implant surface more noticeable and could require additional fat to be added. In contrast, placing implants under the chest muscle (subpectoral) is known for its long-term safety and effectiveness. Both methods are considered safe, but they have different pros and cons that might affect recovery and satisfaction with the results. ^{1 5 6 7 8}

Who Is on the Research Team?

Jing Zhang, MD

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Female patient aged 20-80

All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction

Able to provide informed consent

Exclusion Criteria

You cannot have immediate breast reconstruction due to medical reasons.

You have a history of smoking.

Patients with BMI > 40

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with either prepectoral or subpectoral implant placement

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain, complications, and patient-reported outcomes

12 months

Multiple visits (in-person and virtual)

Data Analysis and Dissemination

Data collection, analysis, and dissemination of results

12 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Prepectoral implant placement Experimental Treatment 1 Intervention

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

Group II: Subpectoral implant placement Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

Prepectoral acellular dermal matrix (ADM)-assisted breast reconstruction shows a safety profile comparable to partially submuscular reconstruction, with similar postoperative complications and improved recovery metrics like pain and range of motion.

Aesthetic outcomes are influenced by factors such as body mass index, fat grafting, and implant cohesiveness, with higher BMI and fat grafting reducing visible rippling, while radiation treatment increases the risk of capsular contracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile and Predictors of Aesthetic Outcomes After Prepectoral Breast Reconstruction With Meshed Acellular Dermal Matrix. Belmonte, BM., Campbell, CA.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6996627/

Multicentre study of prepectoral breast reconstruction using ... This multicentre audit examined surgical outcomes following prepectoral reconstruction using acellular dermal matrix (ADM).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5640360/

Prepectoral Implant-Based Breast Reconstruction - PMC Prepectoral implant placement with total ADM coverage avoids disruption of PMM function, animation deformity, and implant malposition. Using this technique, ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12978-0

Does the use of Acellular Dermal Matrices (ADM) in women ... This review suggests a lack of significant differences in most complications between ADM use and non-use for pre-pectoral IBBR.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681523005454

Do we need acellular dermal matrix in prepectoral breast ... Long-term complications included rippling (3.3% in ADM and 5.1% in no-ADM cohorts) and capsular contracture (6.8% and 3.4%, respectively). This meta-analysis ...

5. scientificarchives.com scientificarchives.com/article/acellular-dermal-matrix-in-prosthetic-breast-reconstructive-surgery-with-prepectoral-technique-a-literature-review

Acellular Dermal Matrix in Prosthetic Breast Reconstructive ... We performed a brief review of the literature about the use of ADMs in prepectoral direct-to-implant breast reconstruction, also discussing about the costs and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34100818/

Safety Profile and Predictors of Aesthetic Outcomes After ... Prepectoral meshed ADM breast reconstruction has an equivalent safety profile to partially submuscular ADM-assisted reconstruction and early ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681524005953

Does the use of acellular dermal matrices in pre-pectoral ... Participants who felt that ADM use improved cosmetic outcomes and reduced long-term complications were a relative majority at 43.8% and 40.6%, respectively.

8. abs.amegroups.org abs.amegroups.org/article/view/7173/html

An 11-year retrospective analysis of clinical outcomes after ... Conclusions: Prepectoral implant reconstruction is associated with low complication rates comparable to subpectoral implant reconstruction. Rates of capsular ...