An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas

Abstract

PurposeIt has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn’s disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal fistulas without any concomitant medication.MethodsAn open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 (ClinicalTrial.gov identifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted.ResultsOf 28 patients included, 10 patients (35.7%) showed complete fistula healing (closed, no discharge on palpation) after 8 weeks; seven of these patients, corresponding to 25% of the enrolled patients, remained in remission for up to 31 weeks. At week 8, there was a statistically significant reduction in the discharge visual analog scale (p = 0.04), a significant improvement in the patient-perceived quality of life for the category of embarrassment (p = 0.002), and a trend toward improvement in the other assessment categories.ConclusionsThe treatment was well tolerated, and patient acceptance was high. The results support the efficacy and safety of locally administered activated carbon for the treatment of patients with chronic uncomplicated perianal fistulas not receiving any other medication for fistula problems.

Activated Carbon for Sepsis Prevention and Intervention: A Modern Way of Utilizing Old Therapies

“…Activated carbon can be considered as a candidate to regulate PAMPs and DAMPs levels by selective or/and broad range adsorption of exogenous and endogenous inflammation and sepsis-related pathogens from biological fluids, including blood, plasma, and intestinal juice. There are numerous reports of beneficial AC applications in pre-clinical, clinical studies, and randomized clinical trials [20,[28][29][30][31][32] to confirm AC efficacy and safety for inflammation mitigation and/or MODS prevention and treatment. Table 1 highlights some PAMPs and DAMPs that can be adsorbed by AC.…”

“…AC was shown to exert a positive action on microbiota [19,29,108,109]. Zawadzki et al [20] tested a rectal application of AC (8-24 week duration) in patients with chronic, uncomplicated perianal fistulas who were scheduled for surgery. The etiology of perianal fistulas is believed to be cryptoglandular infection, often in individuals with a previous history of an anorectal abscess, malignancy, Crohn's disease, and radiation therapy.…”

“…It can adsorb different inflammation-related PAMPs and DAMPs by non-selective (broad-range) [10,12,13], selective [14], and combined (non-selective and selective) [15][16][17][18] from biological fluids. AC is administered orally, per rectum, or via the hemoperfusion system for mitigation of different pathological states accompanied by inflammation, and has an impact on different parameters of homeostasis [19][20][21].…”