A prospective randomized clinical trial to compare the effectiveness of pressure therapy, silicone gel sheeting and the combined therapy on post-surgical hypertrophic scar

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A prospective randomized clinical trial to compare the effectiveness of pressure therapy, silicone gel sheeting and the combined therapy on post-surgical hypertrophic scar

 

Author: Lau, Chung-man Joy
Title: A prospective randomized clinical trial to compare the effectiveness of pressure therapy, silicone gel sheeting and the combined therapy on post-surgical hypertrophic scar
Degree: M.Phil.
Year: 2006
Subject: Hong Kong Polytechnic University -- Dissertations
Pressure -- Therapeutuc use
Wounds and injuries -- Treatment
Department: Dept. of Rehabilitation Sciences
Pages: xvii, 200 leaves : ill. (some col.) ; 31 cm
Language: English
InnoPac Record: http://library.polyu.edu.hk/record=b2069736
URI: http://theses.lib.polyu.edu.hk/handle/200/190
Abstract: Hypertrophic scar is very common among the Chinese population after surgeries or deep skin injuries such as burns. It causes pain, itchiness, contractures and deformities. Pressure therapy and silicone gel sheeting are often prescribed as conservative intervention for management of scars. This study aimed to compare the effects of these intervention techniques and its combined effect on scar maturation based on objective scar evaluation methods and using a randomized clinical trial. The prevalence rate of hypertrophic scar formation among Chinese population was high as 74.67% (115 out of 154). 101 subjects agreed to participate in this RCT study. There were 40 males and 61 females with mean age 56.78?0.73. They were then randomly assigned into four groups, namely, the silicone gel group (n=26), the pressure therapy group (n=28), the combined treatment group (n=24) and the control group (n=23). Scar maturation can be measured based on its pigmentation, thickness, vascularity and pliability. An objective scar assessment protocol was developed in this study. The Tissue Ultrasound Palpation System (TUPS) was used to assess the scar thickness. The spectrocolormeter was validated to measure the scar pigmentation and vascularity while the scar pliability based on the Vancouver Scar score (VSS). Pain and itchiness were measured using the VSS score. The TUPS and the spectrocolorimeter were validated prior to their application on the subjects. All subjects were assessed monthly in the initial month, then bi-monthly till the end of the 5th month. Two-way ANOVA in mixed model was used to analyze the progress of scars among 4 groups. There was a significant difference in scar thickness among 4 groups after the intervention programme, with F (9,236) =2.69, p= 0.005. The post-hoc comparison analysis showed that the scar thickness of the pressure therapy group, F (1,236) = 15.33, P < 0.001, and the silicone gel group, F (1,236) = 10.44, p = 0.001 were significantly thinner than the control group (Mean=5.10, SD=0.15). The pressure therapy group was found significantly lower than the control group, F(l,236) = 8.34, p = 0.004, at the three month assessment. However, there was no significant difference in terms of vascularity (redness) and pigmentation (yellowness, lightness) among the four groups of subjects after the intervention. Regarding the scar pliability, the two-way repeated ANOVA in mixed model showed that there is a significant difference among four groups over 5 months with F(9, 236)=3.48, P <0.01. Silicone gel sheeting group was softer than the control group all along 5-month time. There was no significant difference in terms of pain and itchiness among 4 groups. However, it was also found that the combined intervention group did not show better improvement on scar maturation outcomes when compared to silicone gel or pressure therapy intervention. In this study, pressure therapy was found to be the most effective in control of scar thickness and it has taken its effect at the three months intervention when compared to the other intervention group. The silicone gel group was also found effective in control of scar thickness and pliability. The combined therapy group did not demonstrate better or similar effect as the pressure therapy or silicone gel sheeting groups. The two interventions might have different effect on scars. The silicone gel sheeting added underneath the garment may reduce the pressure exerted onto the scar, thus reducing its effect to control the vascular blood flow onto the scar, whereas the padding of pressure therapy affected the hydration effect and oxygen permeability of silicone gel sheeting and lessen the effect on the stratum corneum. Further investigation is warranted to explore their effects on scar.

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