eP824 - Randomized study compares ActiGraft+ Trephine, Laser+ Trephine, and Trephine alone for treating Pilonidal Disease.

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Purpose/Background: Pilonidal Sinus (PNS) disease is a common inflammatory condition that usually affects young patients worldwide. The disease may cause infection, significant discomfort, pain, immobility, burdensome wound care, and loss of work productivity in healthy young adults (1-2). The common treatment is surgical excision of the sinus tracts, followed by primary closure and healing by primary intention or leaving the wound open to heal by secondary intention. In recent years, there has been a significant transition towards less invasive surgical techniques for managing pilonidal sinus, often conducted in outpatient settings (3-4).
ActiGraft is an autologous whole blood clot product, that functions as an extracellular matrix (ECM), protecting the wound cavity and facilitating the healing process. Autologous blood clot treatment was found to be safe and effective in surgical and chronic wounds (5). The blood clot treatment serves not only as a provisional matrix but as a regenerative tissue that can seal the sinus cavity and lead to the formation of new granulation tissue and re-epithelization.
In a single-arm study, 51 patients with PNS were treated with ActiGraft + Trephine surgery. At 3 and 6 months, complete healing was achieved by 82.3% and 91.8% of the patients, respectively.
We hereby present our ongoing randomized comparator study, which aims to compare the safety and efficacy of ActiGraft + Trephine surgery, to Laser + Trephine surgery and trephine surgery alone, in treating pilonidal disease.Methods/Interventions: This prospective, single-center, randomized controlled trial is a three-armed, blinded assessor study. Ninety subjects will be enrolled, and all participants will undergo minimally invasive trephine pilonidal sinus surgery. Randomization will be achieved using a 1:1:1 ratio, with 30 patients allocated to each arm. The three treatment arms include ActiGraft+ Trephine surgery, Laser+ Trephine surgery, and Trephine surgery alone. In the ActiGraft arm. Follow-up visits are scheduled at 1 week, 3 weeks, 6 weeks, 3 months, 6 months, and one-year post-surgery.

PNS Complete healing diagnosis will be initially established through clinical evaluation by the Investigator. Confirmation of diagnosis will be conducted by two blinded assessors during the 3-month follow-up period. PNS recurrence will be assessed based on patient-reported symptoms, via telephone call during the one-year follow-up periodResults/Outcomes: The study is conducted in a large tertiary hospital in Israel. To this point, 66 patients were screened, among them 65 were randomized to one of the 3 study arms. Enrollment is expected to conclude by the end of 2024.Conclusion/

Discussion: In a previous clinical study, ActiGraft + Trephine surgery was found to be safe and effective in treating PNS conditions having a lower recurrence rate at 1 year. When compared to historical published data, ActiGraft coupled with Trephine surgery is suggested to result in better outcomes than Trephine surgery alone and other far more invasive and complex procedures. Given that PNS predominantly affects healthy young adults, achieving timely and durable healing outcomes in this population is of utmost importance. ActiGraft emerges as a promising, innovative, safe, and effective solution, offering a new therapeutic option for patients suffering from PNS disease. Our current study aims to compare the outcome of the different approaches to treat PNS.