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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for breast reconstruction?

Research suggests that prepectoral implant placement with acellular dermal matrix (ADM) can offer better cosmetic results and less pain compared to subpectoral placement, as it avoids muscle injury and related complications. Studies have shown that this method is gaining popularity due to its advantages, such as reduced postoperative pain and avoidance of breast animation deformities. ^{1 2 3 4 5}

Is prepectoral or subpectoral implant placement for breast reconstruction safe?

Both prepectoral and subpectoral implant placements for breast reconstruction have been studied for safety. Prepectoral placement with acellular dermal matrix (ADM) has shown improved pain scores and faster recovery compared to subpectoral placement, with an appropriate safety profile. However, there is limited evidence comparing the two directly, and some studies suggest potential complications with ADM use. ^{1 2 3 6 7}

How does pre-pectoral implant placement differ from sub-pectoral implant placement in breast reconstruction?

Pre-pectoral implant placement involves placing the implant above the chest muscle, which can reduce pain and avoid muscle-related complications like animation deformity (unwanted movement of the breast when the muscle contracts). This method uses acellular dermal matrix (ADM) to support the implant, potentially offering better cosmetic results compared to the traditional sub-pectoral placement, where the implant is placed under the chest muscle. ^{1 2 5 8 9}

Research Team

Jing Zhang, MD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Prepectoral implant placement and complete coverage with porcine acellular dermal matrix: a new technique for direct-to-implant breast reconstruction after nipple-sparing mastectomy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prepectoral Two-Stage Implant-Based Breast Reconstruction with and without Acellular Dermal Matrix: Do We See a Difference? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Prospective Comparison of Short-Term Outcomes of Subpectoral and Prepectoral Strattice-Based Immediate Breast Reconstruction. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Skin-reducing mastectomy and pre-pectoral breast reconstruction using the Braxon® ADM: a single-center experience. [2022]

5. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Optimizing perioperative strategies to maximize success with prepectoral breast reconstruction. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative Complications Following Prepectoral Versus Partial Subpectoral Implant-Based Breast Reconstruction Using ADM: A Systematic Review and Meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Submuscular Implant-Based Breast Reconstruction Using a Musculofascial Pocket Formed by the Pectoralis Major Muscle and the Serratus Anterior Muscle Fascia: A Novel Surgical Approach. [2022]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Single stage, direct to implant pre-pectoral breast reconstruction. [2023]