Pre- vs Sub-Pectoral Breast Reconstruction for Breast Reconstruction

(OPBC-02PREPEC Trial)

Not currently recruiting at 24 trial locations

Overseen By Martin Haug, Prof. Dr. med

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Hospital, Basel, Switzerland

Disqualifiers: Inadequate skin flaps, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether placing breast implants over the chest muscle (pre-pectoral) improves long-term physical comfort and quality of life compared to placing them under the muscle (sub-pectoral) after breast cancer surgery. It targets women undergoing mastectomy (removal of breast tissue) either for treatment or prevention of breast cancer. Ideal participants can complete quality of life surveys and are having skin-sparing or nipple-sparing mastectomies.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance post-mastectomy 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.

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

Research shows that both pre-pectoral and sub-pectoral implant-based breast reconstruction (IBBR) are safe options for patients after a mastectomy. Studies have found that pre-pectoral IBBR offers similar outcomes to sub-pectoral IBBR, with one key advantage: it results in fewer cases of capsular contracture, where scar tissue forms around the implant, causing hardness.

Other research confirms that both methods yield reliable results with comparable complication rates, including the risk of implant loss. For instance, the chance of losing a tissue expander or implant is about 10% for both methods.

These findings suggest that patients can confidently choose either option, knowing both are well-tolerated and thoroughly studied for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pre-pectoral and sub-pectoral implant-based breast reconstruction (IBBR) techniques because they offer unique approaches to breast reconstruction following mastectomy. Unlike traditional methods that typically place the implant under the chest muscle (sub-pectoral), pre-pectoral IBBR involves placing the implant above the muscle, potentially reducing pain and recovery time. Both methods aim to improve aesthetic outcomes and patient comfort, but the pre-pectoral approach might offer a less invasive option with faster recovery. By exploring these different placements, researchers hope to refine reconstruction techniques to enhance patient satisfaction and overall quality of life after surgery.

What evidence suggests that this trial's treatments could be effective for improving quality of life in breast reconstruction?

This trial will compare pre-pectoral and sub-pectoral implant-based breast reconstruction (IBBR) methods. Research has shown that both approaches are effective after a mastectomy. Studies have found that pre-pectoral IBBR often results in fewer cases of capsular contracture, where scar tissue tightens around the implant, with a 46% lower risk compared to sub-pectoral placement. Patients generally report satisfaction with the look and feel of pre-pectoral IBBR, and major issues like animation deformity, where the implant visibly moves with muscle movement, are absent. Both methods have similar complication rates. However, the pre-pectoral approach is gaining popularity due to its safety and effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Walter Weber, Prof. Dr. med

Principal Investigator

Division of Breast Surgery, University Hospital Basel

Are You a Good Fit for This Trial?

This trial is for patients who are having a skin-sparing or nipple-sparing mastectomy and opting for Implant-Based Breast Reconstruction (IBBR) as treatment or prevention of breast cancer. Participants must be able to fill out Quality of Life questionnaires and give informed consent. Those without a clinical need for IBBR or with inadequate skin flaps for pre-pectoral IBBR cannot join.

Inclusion Criteria

Written informed consent according to ICH/GCP regulations prior to any trial specific procedures

I am having or had nipple-sparing or skin-sparing mastectomy with immediate breast reconstruction.

Ability to complete the Quality of Life questionnaires

Exclusion Criteria

My skin flaps are not suitable for breast reconstruction over the chest muscle.

My surgeon decided I don't need immediate breast reconstruction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Immediate Reconstruction

Participants undergo mastectomy and immediate implant-based breast reconstruction

1 week

Hospital stay for surgery

Post-operative Follow-up

Participants are monitored for surgical complications and recovery

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for quality of life and safety outcomes

24 months

Visits at months 1, 6, 12, and 24

What Are the Treatments Tested in This Trial?

Interventions

• pre-pectoral IBBR
• sub-pectoral IBBR

Trial Overview The study compares two types of breast reconstruction after mastectomy: one where the implant is placed under the chest muscle (sub-pectoral), and another where it's placed over the muscle but under the skin (pre-pectoral). The goal is to see which method offers better physical well-being in terms of chest comfort after 24 months.

How Is the Trial Designed?

Group I: pre-pectoral IBBR Active Control 1 Intervention

Group II: sub-pectoral IBBR Active Control 1 Intervention

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1,031

Recruited

2,503,000+

Swiss National Science Foundation

Collaborator

Trials

227

Recruited

457,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9726796/

Prepectoral Versus Subpectoral Implant-Based Breast ... Our results showed that patients receiving prepectoral IBBR experienced fewer capsular contractures (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.32– ...

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

Prepectoral Implant-Based Breast Reconstruction - PMC At a mean follow-up of 485 days, patient satisfaction and cosmetic outcomes have been good, with no significant capsular contractures or animation deformity.

3. abs.amegroups.org abs.amegroups.org/article/view/7394/html

Pre-pectoral implant-based breast reconstruction after ... The evidence available demonstrates that PBR is safe and feasible with the use of meshes but they could eventually be abandoned in the future if preliminary ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681522005782

Subpectoral versus prepectoral two-stage breast ... Prepectoral and subpectoral TE placement had comparable complication rates during the first and second stages of IBBR.

5. journals.lww.com journals.lww.com/prsgo/fulltext/2024/06000/a_single_center_comparison_of_surgical_outcomes.31.aspx

A Single-center Comparison of Surgical ... Prepectoral implant placement continues to gain widespread acceptance as a safe and effective option for breast reconstruction.

6. journals.lww.com journals.lww.com/plasreconsurg/abstract/9900/one_year_outcomes_in_prepectoral_versus.2557.aspx

One-Year Outcomes in Prepectoral versus Subpectoral... Prepectoral and subpectoral approaches to implant-based breast reconstruction (IBBR) are both reliable options for patients following mastectomy.

7. mdpi.com mdpi.com/2072-6694/17/6/925

Oncological Safety of Prepectoral Implant-Based Breast ... Several retrospective studies and meta-analyses have demonstrated that prepectoral IBBR is a safe surgical option, yielding clinical outcomes comparable to the ...

8. aacrjournals.org aacrjournals.org/cancerres/article/83/5_Supplement/P2-15-05/717489/Abstract-P2-15-05-Prepectoral-versus-subpectoral

Abstract P2-15-05: Prepectoral versus subpectoral implant ... Conclusion The results of our systematic review and meta-analysis demonstrated that prepectoral implant-based breast reconstruction is a safe ...