Abstract
Xiapex is a novel non-surgical intervention for the treatment of Dupuytren's contracture. It comprises a fixed-ratio mixture of two purified collagenolytic enzymes (AUX-I [clostridial type I collegenase] and AUX II [clostridial type II collagenase]) isolated from the medium of Clostridium histolyticum. Xiapex targets the contracture through the injection of enzymes into the pathologic diseased cords.
The objectives of this study were to evaluate the safety and efficacy of Xiapex in patients with Dupuytren's Contracture, the recovery and associated use of health care resources. The study commenced in June 2011 and was completed in 11 months. 15 patients were screened for the study, 12 patients were eligible (10 male:2 female). All 12 patients completed the trial and 2 patients received multiple injections, one had two fingers affected and the other had two joints affected in one finger.
Following screening visit to determine patient suitability, the patient received their first injection usually within 7 days. Xiapex was injected directly into the palpable cord. 24 hours after injection patients were reviewed and a “finger extension procedure” was performed if the cord had not spontaneously ruptured. Patients were then followed up at 7 days, 30 days and 6 months. Assessments at each visits included: Finger Goniometry, Physician and Subject Global Assessment and Satisfaction, Health Care Resource Utilization and URAM (function assessment) and adverse events.
Of the 14 cords injected all ruptured after finger extension. No patient experienced any serious adverse events, but a number of more minor adverse events were recorded including skin tears, pain at injection site, swelling and bruising. At the time of final follow-up recurrence rates were 14%
In conclusion, Xiapex is suitable for appropriately selected patients who are affected by Dupuytren's contractures and who have a well-developed palpable cord.
