A randomized clinical trial to study the effect of silicone gel dressing and pressure therapy on posttraumatic hypertrophic scars.

To investigate the effect of pressure therapy (PG), silicone gel sheeting (SGS), and combined therapy on the management of posttraumatic hypertrophic scar (HS) using a randomized controlled clinical trial. A total of 104 subjects with HS mostly resulting from burns and scald injuries (63 men and 41 women; average age: 21.8 +/- 18.7 years) were recruited from Jiangsu People's First Affiliated Hospital in Nanjing, China. The mean scar formation period was 14.9 +/- 30.8 months. All subjects were randomly allocated into four groups, namely the PG, SGS, combined PG and SGS groups, and single-blinded control group for the treatment of 6 months. Standardized scar assessments (pigmentation, vascularity, thickness, pain, and itchiness) were conducted before the intervention, 2, 4, and 6 months of the intervention, and 1 month after completion of the program, respectively, to observe the progress of the treatments. The results showed that the combined therapy seemed to be more effective in improving the thickness of scar after 2 months of intervention (P < .001). After 6 months of intervention, both the combined therapy group and the PG group showed significant improvement in scar thickness. The improvement in scar thickness was most significant in the combined therapy group. SGS was found to be more effective in alleviating the pain and pruritus rather than the scar thickness. This randomized clinical trial has demonstrated the evidence of the effect of combined PG and gel intervention on posttraumatic HS. The PG group showed an improvement in scar thickness too. Further studies are needed to investigate the biomechanical and physiological effect that PG and gel sheeting would exert on the scar tissues.

RCT Entities:   Population Interventions Outcomes