Impact of Surgihoney Reactive Oxygen on surgical site infection (SSI) after complex abdominal wall reconstruction (AWR) of grade 3 and 4 ventral Hernias: A single arm pilot study

Abstract Introduction Following Abdominal Wall Reconstruction (AWR) wound infections occur in over one third of patients and rates can be even higher in entero-cutaneous fistula repair. A novel antimicrobial gel has been engineered by microbiologists called Surgihoney Reactive Oxygen (SHRO). SHRO gel will be applied to a group of patients. We aim to conduct a pilot case series with the hope to show a reduction in local wound complications after SHRO application. Methods and analysis A single arm pilot study of AWR patients will be carried out on patients with grade 3 and 4 (VHWG grade) ventral hernias. Patients' pre-operative wounds will be graded according to the CDC classification scale. Post operatively the wounds will be classified according to the Wilson surgical site infection classification. Intervention: SHRO will be applied after abdominal fascial closure and before skin closure through a standardised method. Our results from the series will be compared to our retrospective standard wound care results. Data will be collected from 01.03.2017 to 01.11.2017. Primary outcome: Surgical site infection within 30days of surgery, assessed by clinicians at 5, 15 and 30days and by patient's self-report for the intervening period. Secondary outcomes include other SSOs (haematoma, seroma, wound dehiscence, skin necrosis), duration of stay in hospital, reported side effects from local treatment and other systemic postoperative complications. We will aim for a cohort of 40 patients. Conclusions This study will provide an assessment of methods and feasibility of recruiting and following up patients who are treated with SHRO. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost effectiveness of SHRO in wound management following AWR. This may act as a model for the management of wounds in complex patients undergoing AWR.