Post-surgical incision healing complications can vary in severity from mild cases needing local wound care to serious cases with multiple reoperations and a high morbidity. Applying NPWT as a post-operative dressing for closed incisions has demonstrated a number of benefits.
200 patients undergoing bilateral reduction mammoplasty and who were suitable for incisional NPWT were recruited into a prospective, randomised, intra-patient, comparative, open, multi-centre study (6 centres in USA, South Africa, France and The Netherlands). Each patient was treated with both PICO™ and standard care for up to 14 days to enable a within patient comparison. Follow-up assessments were carried out to evaluate the difference in incision healing complications between PICO and std care up to 21 days post surgery (Primary Endpoint). Healing complications were defined as delayed healing (incision not 100% closed by 7 days), or occurrence of dehiscence or infection within 21 days. Differences in scar quality and aesthetic appearance were also assessed using The Patient and Observer Scar Assessment Scale (POSAS) and The Visual Analogue Scale (VAS) at 42 and 90 days.
Significantly fewer overall healing complications had occurred by 21 days post surgery when treated with PICO compared to Standard Care (5%, p=0.004) (95% CI 2.0% to 9.2%). Treatment with PICO resulted in significantly fewer incidences of dehiscence compared to standard care (32 patients (16.2%) v 52 patients (26.4%) by day 21 (p<0.001). Scar quality as measured by the VAS and POSAS scoring systems was shown to be significantly better on PICO treatment than Standard Care, both at the 42 day and 90 day assessment (p<0.001).
Treatment of closed surgical incisions with a NPWT system in the form of PICO leads to a statistically significant reduction in incision healing complications, in particular a significant reduction in post-surgical dehiscence and a statistically significant improvement in scar quality within the first 3 months after the procedure.