The use of the PEAK PlasmaBlade™ in DIEP/MS-TRAM breast reconstruction surgery compared to conventional diathermy - a single centre, double blinded randomised controlled trial

Introduction: Electrosurgery makes dissection with simultaneous haemostasis possible. Inadvertently produced heat can cause injury to the surrounding tissue that may result in wound healing problems and an increased rate of seroma formation. The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage. Method: A double blinded, single centre, randomised controlled trial was conducted, including a 108 abdominally based free flap breast reconstruction patients who had their flap raise performed with either the PPB (n=56) or conventional diathermy (n=52). Data were collected during their in-patient stays and at the 2-and 6-week clinic follow-up appointments. The primary outcome value for which the study was powered was the number of days the abdominal drains were required. For statistical analysis the independent t-test, Mann-Whitney U test, Pearson Chi-Square test and Fisher’s Exact test were used. Uni-and multivariable regression were used to identify and correct for predictors and confounders. Results: Baseline characteristics were similar between the groups, except for a significantly lower flap weight in the PPB group for which was corrected. The median number of days the drains were required, was 6.0 (Interquartile Range (IQR) 5.0 – 8.8) days for the diathermy and 5.0 (IQR 4.0 – 8.0) days for PPB, this was not significant (p=0.48). Median amount of drain fluid was similar with 342.5 mL (IQR 233.8 – 618.8) in the diathermy and 355.0 mL (IQR 228.8 – 532.5) in the PPB group (p=0.68). In recovery, post-operative pain scores were significantly higher in the PPB group (2/10 vs 4/10, p=0.002). Three pro-inflammatory cytokine in the drain fluid showed a trend towards lower values in the PPB group on day 0,1 and 2 but did not reach statistical significance. Complications were similar between the groups (p>0.24). At the 2week follow-up appointment there was a tendency towards less abdominal seromas on abdominal ultrasound in the PPB group (70.6% vs 54.5%, p=0.09) which were significantly smaller (62.8cm3 (IQR 22.0 – 110.0) vs 45.6cm3 (IQR 16.8 – 97.9), p=0.04). Due to spontaneous re-absorption presence and size of the identified seromas did not significantly differ anymore at the 6-week follow-up appointment. Conclusion: Abdominally based free flap harvest performed with the PPB did not result in a significant reduction of drain requirement time, total output or inflammatory cytokines. Higher pain scores immediately post-operatively were recorded in the PPB group but could be the consequence of other factors. The abdominal ultra-sound performed at the 2-week follow-up appointment showed a tendency towards less seroma collections which were significantly smaller in the PPBgroup. Therefore,the PEAK PlasmaBlade™ device could reduce earlypostoperative seroma formation.