Perf-Act BreCon: A Prospective Case-control Study to Compare Tissue Perfusion between RetrActors and Non-retractors during Immediate Breast ReConstruction

To collect clinical evidence to demonstrate the difference in trauma caused to the breast tissues due to current surgical practices.

In the UK, 55,000 cases of breast cancer are diagnosed every year and is presently the most common cancer in women1. Over two million new breast cancers are diagnosed worldwide2. Surgery remains the mainstay of breast cancer treatment, and post-operative complications can delay adjuvant therapy3, potentially contribute to systemic cancer recurrence4, affect psychosocial well-being, and increase pressure on healthcare resources5,6.

Despite advances in mastectomy and immediate breast reconstruction, post-surgical complications remain common7, and no intra-operative intervention, such as nitroglycerine ointment to skin flap8, high-frequency radiosurgery9 or heat preconditioning10 has been widely adopted to mitigate this risk. Tissue trauma during surgery is a recognised contributor to compromised skin-flap perfusion and subsequent complications. Surgical retractors, routinely used to expose the operative field, may potentially exert forceful pressure on soft tissues. They are perceived by many breast surgeons as a leading cause of skin injury during reconstruction11, including in an independent multi-speciality survey conducted by Cambridge University post-docs as an adjunct to the present study.

Gentler tissue-handling techniques may reduce tissue trauma and improve perfusion; however, objective clinical evidence comparing these approaches is limited.

An alternative, gentler approach is to spread the fingers of the non-dominant hand, which allows a wider visual angle at superficial levels but suffers from limited depth reach. Additionally, prolonged separation leads to fatigue that, over time, can contribute to musculoskeletal injury (e.g., tendinitis, carpal tunnel syndrome)12-14 with a negative impact on a costly, highly trained surgical workforce15.

This study aims to compare breast tissue perfusion during mastectomy with retractors versus fingers spread (like V) to separate the tissue plane between the preserved skin flap and the breast tissue to be excised. Perfusion is objectively measured using indocyanine green (ICG) fluorescence imaging. By quantifying differences in tissue perfusion, the study seeks to inform best surgical practice and support the development of evidence-based strategies to minimise tissue trauma and improve patient outcomes.

The PerfAct study is a prospective case-control, multi-centre study.

 Population: Women 18 years of age and over undergoing bilateral mastectomy with immediate reconstruction for either bilateral breast cancer or for risk reduction.

Intervention: Perform one side of the bilateral mastectomy using fingers spread (like V) to separate the tissue plane between the preserved skin flap and the breast tissue to be excised.

Comparator: Perform the other side of the bilateral mastectomy (hence, patient variables remain constant) using standard retractors.

1. Primary Outcome – The relative difference (%) in blood perfusion between each breast in the same patient. Blood perfusion will be measured at 3 time-points (T1: baseline, T2: when switching from fingers to retractors to complete dissection at depth, T3: end). The relative difference is defined as the difference, D, in blood perfusion between T2 and T1. The t-test will be applied to the between-breast difference on D.

2. Secondary Outcomes (30-day in line with NHS Hospital Episode Statistics):

 All data is recorded by the NIHR Clinical Research Nurses into the REDCap database monitored by the CCTU-CT monitoring team.

 The study (endorsed by the Association of Breast Surgery, UK) aimed to recruit at least 30 participants across three sites. Recruitment ended in December 2025, with 34 participants recruited, 32 of whom should be analysable by the end of the study by the end of January 2026.

Surgeons believe retractors harm preserved soft tissues during dissection, yet attention to and funding for improving this factor during surgery are lacking because there is a lack of objective evidence of the problem. The PerfAct trial will provide the first insights into the critical gap in the standard retraction method’s role in preserving perfusion of preserved soft tissues during dissection. We will share findings through scientific meetings, publications and social media. Findings could help mitigate one intra-operative factor during soft-tissue open surgery, including breast.

Email: cuh.perfact.brecon@nhs.net for further information