title: Evaluation of the effectiveness of a polyhexanide and propyl betaine-based gel in the treatment of chronic wounds.
abstract: OBJECTIVE
  The objective of this multicenter observational clinical study was to evaluate the therapeutic effects of a polyhexanide and propyl betaine-based gel in the treatment of patients of every age, affected by chronic skin wounds.
  
  
  METHODS
  One hundred twenty-four patients (60% females, from 4-day-old to 91-year-old, mean age 59) were treated with polyhexanide/propyl betaine (Prontosan® Wound Gel, B. Braun) applied directly on the surface of the wound and in the possible undermining, in combination with a secondary dressing. At the baseline visit and at subsequent checks were evaluated the wound diameter and characteristics (the wound bed and the surrounding skin and edges appearance, level and type of exudate) and local pain at dressing change.
  
  
  RESULTS
  The assessment and analysis between the initial visit and the final one showed the following results: the wound size and pain characteristics have decreased substantially and significantly (P<0.001) both in the size of the wounds (length: -17.5 ± 21.4 cm, width: -15.5 ± 21.1 cm; area: -8.3 ± 16.7 cm²) and in the intensity of pain perceived by the patient (Visual Analogue Scale [VAS]: -4.67 ± 2.7; Face, Legs, Activity, Cry, Consolability [FLACC] Scale <1 ± 4); for patients younger than 3 years, the scale used was FLACC. Wound bed: it was found a significant increase in the percentage of improvement in patients; 90% of them showed a reduction in the wound size, while 80% of them showed a relative reduction in pain compared with that observed during the baseline visit, with the wound bed cleansed, granulating or re-epithelializing. Just as significant was the decrease in percentage of subjects with wounds with fibrinous and partially necrotic bed, and/or with biofilm. Edges of the wound and periwound skin: the percentage of patients who have shown during the treatment an improvement in the clinical condition both of the wound edges and the surrounding skin has significantly increased, with a number of cases (75%) who have reached complete skin integrity. In a smaller percentage, already at the initial visit, the wound edges (28%) or the peristomal skin (18%) have been found undamaged. Exudate: there was a reduction in the level of exudate, with 74% of patients who showed no exudate at the final visit, compared with 15% of patients with non-exudative wounds at baseline.
  
  
  CONCLUSIONS
  The treatment of chronic skin wounds through the use of a polyhexanide/propyl betaine-based gel, in combination with a secondary dressing, showed significant improvements, such as a 30% reduction of pain at dressing change, the reduction in the size and characteristics of the wounds and a reduction in the levels of exudate. All these factors have contributed to a reduction in the number of dressings, thus reducing the overall cost of treatment.
authors.affiliation: Servizio di Vulnologia, Policlinico Militare "Celio", Roma, Italia - ciemmedi@gmail.com.
authors.forename: C M
authors.initials: CM
authors.lastname: Durante
authors.forename: A
authors.initials: A
authors.lastname: Greco
authors.forename: O
authors.initials: O
authors.lastname: Sidoli
authors.forename: C
authors.initials: C
authors.lastname: Maino
authors.forename: A
authors.initials: A
authors.lastname: Gallarini
authors.forename: G
authors.initials: G
authors.lastname: Ciprandi
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001622:Betaine / Q000008:administration & dosage* / Q000191:economics; D001645:Biguanides / Q000008:administration & dosage* / Q000191:economics; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D003646:Debridement; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000191:economics; D004338:Drug Combinations; D005260:Female; D005782:Gels / Q000008:administration & dosage; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D008297:Male; D008875:Middle Aged; D009779:Occlusive Dressings; D010147:Pain Measurement; D016896:Treatment Outcome; D014945:Wound Healing; D014947:Wounds and Injuries / Q000188:drug therapy* / Q000191:economics / Q000628:therapy
chemical_list: D001645:Biguanides; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C031233:polihexanide; D001622:Betaine