title: A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers.
abstract: OBJECTIVE
  This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management.
  
  
  METHODS
  Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing.
  
  
  RESULTS
  Mean GFD-N wear time was 3.2 days per subject. Mean wound area decreased from 10.1 cm2 at baseline to 5.1 cm2 at four weeks (p<0.001) and healed in five subjects (11%). The surrounding skin improved or remained stable in all but one subject. When compared with pre-study dressings, ulcer pain decreased for GFD-N, both with the dressing in place (p<0.001) and on dressing removal (p<0.001). Of final investigator ratings for 45 subjects, most were 'excellent' for ease of application (89%), ease of removal (96%), conformability (67%) and overall performance (58%). Five subjects experienced adverse events; none were serious or dressing-related.
  
  
  CONCLUSIONS
  This small study demonstrates that GFD-N was safe, effective and convenient for wound healing, exudate management, pain/comfort and ease of use.
authors.affiliation: Dermatologische Gemeinschaftspraxis, University Freiburg, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Vanscheidt
authors.forename: K C
authors.initials: KC
authors.lastname: Münter
authors.forename: W
authors.initials: W
authors.lastname: Klövekorn
authors.forename: F
authors.initials: F
authors.lastname: Vin
authors.forename: J-P
authors.initials: JP
authors.lastname: Gauthier
authors.forename: A
authors.initials: A
authors.lastname: Ukat
mesh_terms: D000328:Adult; D000368:Aged; D001458:Bandages; D005122:Exudates and Transudates; D005260:Female; D005782:Gels; D006801:Humans; D007871:Leg Ulcer / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D014945:Wound Healing
chemical_list: D005782:Gels