title: PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial.
abstract: BACKGROUND
  Postoperative adhesions constitute a substantial clinical problem in hand surgery. Fexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired hand recovery. This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions, and correspondingly improving hand function, in flexor tendon repair surgery.
  
  
  METHODS
  This prospective, randomised, double-blind trial included 138 patients admitted for flexor tendon repair surgery. PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon. Efficacy was assessed by total active motion of the injured finger, tip-to-crease distance, sensory function, tenolysis rate and grip strength, and safety parameters were followed, for 12 months post-surgery.
  
  
  RESULTS
  The most pronounced difference between the treatment groups was observed at 6 months post-surgery. At this timepoint, the total active motion of the distal finger joint was improved in the PXL01 group (60 vs. 41 degrees for PXL01 vs. placebo group, p = 0.016 in PPAS). The proportion of patients with excellent/good digit mobility was higher in the PXL01 group (61% vs. 38%, p = 0.0499 in PPAS). Consistently, the PXL01 group presented improved tip-to-crease distance (5.0 vs. 15.5 mm for PXL01 vs. placebo group, p = 0.048 in PPAS). Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments (FAS: 74% vs. 35%, p = 0.021; PPAS: 76% vs. 35%, p = 0.016). At 12 months post-surgery, more patients in the placebo group were considered to benefit from tenolysis (30% vs. 12%, p = 0.086 in PPAS). The treatment was safe, well tolerated, and did not increase the rate of tendon rupture.
  
  
  CONCLUSIONS
  Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery. Further clinical trials are warranted to determine the most efficient dose and health economic benefits.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01022242; EU Clinical Trials 2009-012703-25.
authors.affiliation: Department of Surgical Science, Hand Surgery, Uppsala University, Uppsala, Sweden; Uppsala University Hospital, Uppsala, Sweden.
authors.forename: Monica E
authors.initials: ME
authors.lastname: Wiig
authors.affiliation: Department of Clinical Sciences Malmö - Hand Surgery, Lund University, Skåne University Hospital, Malmö, Sweden.
authors.forename: Lars B
authors.initials: LB
authors.lastname: Dahlin
authors.affiliation: Department of Hand Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Fridén
authors.affiliation: Department of Hand Surgery, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Hagberg
authors.affiliation: Department for Orthopaedics, Unit for Hand Surgery, Odense University Hospital, Odense, Denmark.
authors.forename: Sören E
authors.initials: SE
authors.lastname: Larsen
authors.affiliation: Pharma Consulting Group Solutions AB, Uppsala, Sweden.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Wiklund
authors.affiliation: Pergamum AB, Stockholm, Sweden.
authors.forename: Margit
authors.initials: M
authors.lastname: Mahlapuu
mesh_terms: D000328:Adult; D005260:Female; D005383:Finger Injuries / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery; D005384:Finger Joint / Q000187:drug effects / Q000503:physiopathology; D006225:Hand / Q000503:physiopathology* / Q000601:surgery*; D018737:Hand Strength; D006801:Humans; D006820:Hyaluronic Acid / Q000737:chemistry*; D007781:Lactoferrin / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D010349:Patient Compliance; D016059:Range of Motion, Articular / Q000187:drug effects; D020127:Recovery of Function / Q000187:drug effects; D012677:Sensation / Q000187:drug effects; D013708:Tendon Injuries / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: C570338:PXL01 peptide; D006820:Hyaluronic Acid; D007781:Lactoferrin