AIM: To evaluate the effectiveness of a silicone gel in treating surgical wounds compared with a control group of the same phenotype and same scar site for which a placebo was advised. METHODS: This was a randomized controlled trial, carried out in a dermatology department of a university hospital. In total, we studied 110 patients (55 men, 55 women) who had undergone outpatient surgery at the Department of Dermatology, University of Florence, between May and July 2005. The patients were divided into two groups: a treatment group (group A) and a control group (group B). Subjects (n = 65) in group A were prescribed silicone gel to be applied to the wound twice a day for 60 days after the removal of stitches. Subjects (n = 45) in group B were prescribed the use of zinc oxide cream. All subjects, in both study and control groups, were examined by the same dermatologists every month for 3 months after surgery, then every 2 months for a total follow-up of 8 months from the date of surgery. RESULTS: In the treatment group, only 18 patients (27%) had formation of a nonphysiological scar: diastasic scar in 10 patients (15%), hypertrophic scar in 6 (9%) and atrophic scar in 2 (3%). No keloid scars were recorded. In the control group, 25 (55%) had an altered scar: keloid scars in 5 patients (11%), hypertrophic scar in 10 (22%), diastasic scar in 8 (18%) and atrophic scar in 2 (4%). CONCLUSIONS: The results of this study indicate that silicone gel is able to reduce the formation of keloid and hypertrophic scars and the signs/symptoms associated with the healing process (paraesthesia, pulling sensation, alterations in colour).
RCT Entities:
AIM: To evaluate the effectiveness of a silicone gel in treating surgical wounds compared with a control group of the same phenotype and same scar site for which a placebo was advised. METHODS: This was a randomized controlled trial, carried out in a dermatology department of a university hospital. In total, we studied 110 patients (55 men, 55 women) who had undergone outpatient surgery at the Department of Dermatology, University of Florence, between May and July 2005. The patients were divided into two groups: a treatment group (group A) and a control group (group B). Subjects (n = 65) in group A were prescribed silicone gel to be applied to the wound twice a day for 60 days after the removal of stitches. Subjects (n = 45) in group B were prescribed the use of zinc oxide cream. All subjects, in both study and control groups, were examined by the same dermatologists every month for 3 months after surgery, then every 2 months for a total follow-up of 8 months from the date of surgery. RESULTS: In the treatment group, only 18 patients (27%) had formation of a nonphysiological scar: diastasic scar in 10 patients (15%), hypertrophic scar in 6 (9%) and atrophic scar in 2 (3%). No keloid scars were recorded. In the control group, 25 (55%) had an altered scar: keloid scars in 5 patients (11%), hypertrophic scar in 10 (22%), diastasic scar in 8 (18%) and atrophic scar in 2 (4%). CONCLUSIONS: The results of this study indicate that silicone gel is able to reduce the formation of keloid and hypertrophic scars and the signs/symptoms associated with the healing process (paraesthesia, pulling sensation, alterations in colour).