Long-term outcomes of human acellular dermal matrix plug in closure of complex anal fistulas with a single tract.

Background: Bioprosthetic plugs represent a promising technique for the treatment of anal fistula simple because they allow simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and subsequent surgical options if needed. However, success rates vary widely.

Objective: The aim of this study was to assess long-term outcome in patients treated with an acellular dermal matrix plug for closure of complex single-tract anal fistulas.

Design: This was a retrospective analysis of a prospective database.

Setting: The study was conducted at a university hospital in Beijing, People's Republic of China.

Patients: The study population comprised 114 patients treated between January 2007 and May 2010 for complex high transsphincteric anal fistula with a single tract.

Intervention: Fistulas were treated with an acellular dermal matrix plug derived from donated human skin.

Main Outcome Measures: The main outcome measures were fistula closure rate and postoperative incontinence (Wexner scores).

Results: No mortality or major complications were observed. The overall success rate was 54.4% (62/114), with a median follow-up of 19.5 (range, 11-46) months. Of the 52 patients with plug failure, 11 (21%) had plug extrusion and 9 (17%) had sepsis. Most plug failures occurred within 30 days, with only 1 plug failure occurring 6 months after surgery. On multiple logistic regression analysis, smoking (P < .001), long distance between external opening (P < .001), and performance of the operation by a nonexpert surgeon (P = .018) were significantly associated with plug failure. Of 40 patients who underwent cutting seton placement after plug failure, 33 (82.5%) reported a successful outcome. However, the rate of incontinence 6 months after seton placement was 75% (30/40), whereas the rate in the overall study population 6 months after insertion of the ADM plug was 1.75% (2/114; P < .001).

Limitations: This study was limited by its retrospective nature.

Conclusions: Given the low morbidity and relative simplicity of the procedure, we suggest that an acellular dermal matrix plug is a reasonable option for closure of complex anal fistulas with a single tract.