Incisional negative pressure wound therapy (PrevenaTM) vs. conventional post-operative dressing after immediate breast reconstruction: a randomized controlled clinical trial

Abstract

Abstract Background Surgical complications following breast reconstruction remain a significant concern. This study aimed to investigate if incisional negative pressure wound therapy (iNPWT) using Prevena™ provides superior wound treatment for patients undergoing immediate breast reconstruction (IBR) compared to conventional postoperative dressing. Additionally, we investigated whether intraoperative indocyanine green angiography (ICG-A) could predict and prevent postoperative complications. Methods A randomized controlled study (RCT) comprising 39 patients was conducted. The primary outcome was time until surgical drain removal. ICG-A was applied to evaluate tissue perfusion and compared to rate of postoperative complications. Patients were followed for one year, including postoperative complications, quality of life (QoL), scar evaluation, incidence of lymphedema and timely administration of adjuvant therapy. Results No significant differences were observed in time to surgical drain removal, hospitalization or incidence of postoperative complications between the two groups. Analysis revealed no significant association between ICG-A results and postoperative complications. After one year, both groups exhibited similar QoL and satisfaction with scars. One patient developed lymphedema during follow-up, and adjuvant treatment was timely administered in 82%. Conclusions This RCT investigated iNPWT by Prevena™ compared to conventional postoperative dressing in IBR using implants or tissue expanders. ICG-A was applied to assess tissue perfusion and compared to postoperative complications. We did not find any significant differences in recovery time, hospitalization duration, postoperative complication rates, QoL, or scar satisfaction between the two groups within a one-year follow-up. Additionally, there were no significant association between ICG-A and postoperative complications. Larger randomized studies incorporating intraoperative ICG-A are needed to obtain higher quality data. Level of Evidence: Level I, Risk/Prognostic