PerfAct BreCon Study
Research type
Research Study
Full title
A Prospective Case-control Study to Compare Tissue Perfusion between RetrActors and Non-retractors during Immediate Breast ReConstruction
IRAS ID
330226
Contact name
Amit Agrawal
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Grant no.10073306, Innovate UK
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
To enable a clear view of the operative field during surgery, surgical tools called retractors are used to forcefully lift tissue to allow access for the surgeon. A forceful lift can contribute to tissue injury and consequent complications.
Tissue injury is more pronounced in soft-tissue surgery such as mastectomy (removal of the whole breast), where much of the skin overlying breast tissue that is being removed must be preserved to close the wound safely. This is even more vital if immediate breast reconstruction is being performed as the whole skin envelope is required. During the operation, breast tissue is removed through a rent, held apart by retractors, of which the metal edges can damage the surrounding skin. This skin flap loses its main blood supply when the breast tissue is removed. Hence, any further injury on an already compromised skin contributes to post-operative complications that can delay post-operative chemotherapy or radiotherapy, vital for patient survival.
An alternative, gentler approach that surgeons use is by spreading apart their fingers (like a ‘V’) of the non-dominant hand with the dominant hand operating instruments in between the fingers of the ‘V’. Although this allows a wider visual angle at superficial levels, it suffers from limited depth reach, leading to the continued use of retractors. Additionally, prolonged finger spreading leads to fatigue that, in the long-term, can cause damage to surgeons’ hands.
Hence, there is a need to evaluate this problem and find a solution scientifically. The proposed study will primarily measure mastectomy skin-flap perfusion during surgery and compare retractor-based and fingers-only dissection. Data will be correlated with post-operative complications, including questionnaires to evaluate patients' and surgeons’ operative experience.
Evidence from this study would provide an evidence base to support the development of a new surgery tool that is intended to reduce tissue damage and complication risk.REC name
East of Scotland Research Ethics Service REC 2
REC reference
23/ES/0046
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion