The role of PREVENA vacuum dressings in patients undergoing breast surgery affecting both sides

INTERVENTION: This is a single centre blinded study (wound assessing clinicians are blinded). Patients are randomised in a 1:1 fashion. All enrolled patients will be undergoing bilateral surgery and shall be included in both the control and intervention arms of the study. Patients will have a conventional dressing (control arm) applied to one breast and a PREVENA Incision Management System (intervention arm) applied to the contralateral breast. At this institution, conventional dressings comprise steristrips and an Opsite dressing. Occasionally (in the case of allergy/sensitivity), Cosmopore dressings or Dermabond glue are used. The laterality of the control and intervention arm dressings will be randomised after skin closure, just prior to dressing application. Randomisation will be conducted by opening a sealed blank envelope at the end of the operation, which will state the laterality of the Prevena dressing for the patient, with an equal chance of being the “cancer side” or the “non‐cancer side”. As randomisation will be performed after skin closure, surgeons will essentially be blinded. Clearly, it is not possible to blind the patient. At 1‐week follow up, the patient will be seen by the surgeon who will remove the dressings. After this clinical follow‐up appointment, the research nurse will review the patient to record the study outcome measures as listed above. Research personnel collecting data will be blinded with regards to the laterality of the dressings. In cases requiring aspirating of collections, the ultrasonographer will be blinded as dressings will have already been removed by the surgeon. CONDITION: Patients undergoing a mammoplasty procedure for cancer ; Surgery PRIMARY OUTCOME: The overall occurrence of surgical site complication (SSC) rate at 6 weeks. Patients who experience any of the following complications (infection, necrosis, wound dehiscence) will be counted as an occurrence. SECONDARY OUTCOME: ; Assessed clinically 1, 2 and 6 weeks unless otherwise stated:; 1. Infection occurrence as binary outcome (yes/no) for each patient; 2. Clinical assessment using the ASEPSIS scoring system; 3. USS for all patients who have clinical signs of infection (as per validated score system); 4. If collection seen, USS guided aspiration, documenting volume and fluid type (1. Pus, 2. Seroma, 3. Fat necrosis); 5. Skin/nipple necrosis evaluated in the following ways:; 5.1. Skin/nipple occurrence as binary outcome (yes/no) for each patient; 5.2. Percentage of skin necrosis of the total wound length for each patient; 5.3. Percentage of nipple necrosis of the total nipple area for each patient; 6. Wound dehiscence occurrence as binary outcome (yes/no) for each patient; 7. Pain measured using visual analogue scale (1‐10); 8. Return to theatre (including laterality of problem leading to re‐admission presentation) at 30 days; 9. Re‐admission rates (including laterality of problem leading to re‐admission presentation) at 30 days; INCLUSION CRITERIA: 1. Patients undergoing bilateral Wise pattern or vertical scar mammoplasty surgery 2. Indication for surgery: unilateral oncoplastic procedure with simultaneous contralateral symmetrising surgery 3. English speaking 4. Capacity to consent 5. Age 18‐80 years