Contractubex Versus Corticosteroid Phonophoresis on Burn Hypertrophic Scar
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1 Med. J. Cairo Univ., Vol. 84, No. 2, June: 63-67, Contractubex Versus Corticosteroid Phonophoresis on Burn Hypertrophic car WAFAA H. BORHAN, Ph.D.*; ALAH EL-DIN M. ABD EL-GHANY, Ph.D.**; EMAN M. OTHMAN, Ph.D.* and MOATAZ M. HAHIN, M.c.* The Departments of Physical Therapy for urgery, Faculty of Physical Therapy* and urgery, Faculty of Medicine**, Cairo University Abstract Background: Hypertrophic scar is an exaggerated proliferative response to wound healing that stays within the boundaries of the original wound. Objectives: This study conducted to test which is better for controlling hypertrophic scar, contractubex or corticosteroid phonophoresis. Methods: Thirty patients with hypertrophic scar after thermal burn were randomly classified into two groups with fifteen patients in each group; Group A received contractubex phonophoresis. Group B received triamcinolone phonophoresis. All outcome measures including pliability, height and vascularity of hypertrophic scar were evaluated before and after the treatment program (after 3 months-36 sesseions) by tonometer and modified Vancouver scar scale respectively. Results: howed that Group A that received contractubex phonophoresis had higher statistical significant s than Group B that received triamcinolone phonophoresis. Conclusion: The findings of the study revealed that contractubex phonophoresis was more effective than triamcinolone phonophoresis for treatment of hypertrophic scar after thermal burn. Key Words: Hypertrophic scar after burn Contractubex phonophoresis Corticosteroid phonophoresis. Introduction HYPERTROPHIC scar consists of an abundance of scar tissue confined to the original wound site [1]. Incidence rates of hypertrophic scarring vary from 40% to 70% following surgery to up to 91 % following burn injury, depending on the depth of the wound [2]. Hypertrophic scarring is devastating and can result in disfigurement and scarring that affects Correspondence to: Dr. Wafaa H. Borhan, The Department of Physical Therapy for urgery, Faculty of Physical Therapy, Cairo University quality of life which, in turn, can lead to lowered self esteem, social isolation, prejudicial societal reactions, and job discrimination. carring also has profound rehabilitation consequences, including loss of function, impairment, disability, and difficulties pursuing recreational and vocational pursuits [3]. everal treatment and prevention modalities exist, such as surgical excision, radiation, laser treatment, pressure therapy, intralesional corticosteroid injections, cryotherapy, application of silicone products and various topical and oral medications [1]. Transdermal drug delivery offers an attractive alternative to the conventional drug delivery methods of oral administration and injection. However, the stratum corneum acts as a barrier that limits the penetration of substances through the skin. Application of ultrasound to the skin increases its permeability (sonophoresis) and enables the delivery of various substances into and through the skin [4]. Contractubex gel, a commercial treatment for scars, consists of a mixture of onion extract (cepea extract), heparin sodium, and allantoin. It exerts a softening and smoothing effect on indurated, hypertrophic, painful, and cosmetically-disfiguring scar tissue [5]. For less extensive hypertrophic scarring and keloids, intralesional triamcinolone injections have remained a gold standard in non surgical management. It has been reported that scars treated with triamcinolone acetonide showed decreased levels of the proteinase inhibitors alpha2-macroglobulin and alpha2-antitrypsin in the scar. This leads to decreased collagenase (matrix metalloproteinase) 63
2 64 Contractubex Versus Corticosteroid Phonophoresis on Burn Hypertrophic car degradation which controls excessive and abnormal collagen seen in hypertrophic scars and keloids [6]. It hypothesized that there was no difference between contractubex phonophoresis and corticosteroid phonophoresis on burn hypertrophic scar. o the aim of this study was to compare the effect of contractubex phonophoresis and corticosteroid phonophoresis on pliability, height and vascularity of hypertrophic scar after thermal burn. Patients and Methods Thirty patients with hypertrophic scar selected from Port-aid General Hospital after two months form thermal burn injury they involved in the study from February 2015 to May The patients were divided randomly into two groups by coin method in which the head was for Group A and the tail was for Group B and the groups were equal in number (15 patients for each group); Group A (contractubex phonophoresis), Group B (corticosteroid phonophoresis). Inclusion criteria: - Ages ranged from 21 to 45 years. - All patients had hypertrophic scars after two months or more from thermal burn. - The cause of burn injury for all patients is partial thickness thermal burn either by direct flame or scald. Exclusion criteria: - Patients whom had any previous scars in the treated area. - Patients whom had in the treated area open wound, sever eczema and/or sever fungal infection. - Patients whom had associated injuries. Instruments and procedures: A- Instrumentation: Instruments used in this study were divided into an assessment and treatment. - Assessment instruments: Modified Vancouver burn scar assessment scale. Tonometer. - Treatment instruments: Ultrasonic unit: The unit manufactured by Enraf Nonius, sonopuls 434, used for phonophoresis. Contractubex gel: A commercial treatment for scars, consists of a mixture of onion extract (cepea extract), heparin sodium, and allantoin. Corticosteroid: Triamcinolone. B- Procedure: (Assessment and treatment). - Assessment procedure: Modified vancouver burn scar assessment scale: - Tonometer used for determination of pliability after adding the weights to suit the tension in a scar is rated from 0 to 4. A zero is considered normal skin, 1 is a supple soft scar, 2 is a yielding scar, 3 is a firm scar and 4 is an adherent scar [7]. - Measure the height of the scar, since scars can protrude above the normal skin line A of 0 denotes no height, a of 1 is a scar between 0-2mm, a of 2 is a scar between 2-5mm and a of 3 is a scar over 5mm. - Vascularity was assessed by blanching the scar with a designated clear, square, rigid piece of plastic and observing the rate and amount of blood return as compared to uninjured skin. If no vascularity is visible, the scar is rated a zero for normal. Pink vascularity receives a of 1, red vascularity receives a of 2 and purple receives a of 3 [ 7 ]. - Treatment procedure: Contractubex phonophoresis group (Group A): ufficient quantity of contractubex gel that covers the hypertrophic scar was put over it and the ultra-sound (Pulsed-1 MHZ-1 W/cm) [10] applied directly over the scar by using Contractubex gel in a slow circular movement for 5 minutes (36 sessions-3 sessions/week). Corticosteroid triamcinolone phonophoresis group (Group B): A thin film of coupling medium (gel) was put on hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe over the whole scar then ultra-sound (Pulsed-1 MHZ-1 W/cm) [7] applied directly over the scar in a slow circular movement for 5 minutes (36 sessions-3 sessions/ week). tatistical analysis: Results are expressed as mean ± tandard Deviation (D) or number (%). Paired t-test was conducted for comparison between pre and post treatment mean s measurements of Modified Vancouver car assessment scale in each group. Descriptive statistics and t-test were conducted for comparison of the mean age between groups. Chi squared test was conducted for comparison of sex between groups.
3 Wafaa H. Borhan, et al. 65 Results Thirty patients (25 females and 5 males) with hypertrophic scar after thermal burn participated in this study. Patients were assigned randomly into two equal groups, the first group was the Group (A) who received Contractubex phonophoresis and the second group was the Group (B) who received corticosteroids triamcinolone phonophoresis. Age: Unpaired t-test was used to show difference between the two groups as regards the age. With mean ± D age of Group A was 32.5 ±7.46 years and mean ± D age of Group B was 35 ±8.79 years this test revealed no significant difference between both groups in the mean age s ( p= 0.4) (Table 1). Table (1): t-test for comparison of mean s of age between both Groups (A and B). Group A Group B 32.5 ± ±8.79 Minimum Maximum MD 2.5 t p- 0.4 ignificance N Gender: Chi square revealed no significant difference between both groups in sex distribution (p=0.62) the sex distribution of Group A revealed that there were 3 male with reported percentage of 20% while the number of female was 12 with reported percentage of 80%. The sex distribution of Group B revealed that there were 2 male with reported percentage of 13% and the number of female was 13 with reported percentage of 87% (Table 2). Table (2): The frequency distribution and chi squared test for comparison of sex distribution between both Groups (A and B). Group A Group B χ 2 p- ig. Male 3 (20%) 2 (13%) Female 12 (80%) (87%) 0.62 N Modified vancouver scar assessment scale mean s: Pliability: The mean ± D scar pliability pre treatment of Group A was 2.13 ±0.74 and that post treatment was 1.13±0.35. The mean difference between pre and post treatment was 1 and the percent of change was 46.94%. There was a significant decrease in the mean s (p=0.0001). The mean ± D scar pliability pre treatment of Group B was 2 ±0.84 and that post treatment was 1.53 ±0.51. The mean difference between pre and post treatment was 0.47 and the percent of change was 23.5%. There was a significant decrease in the mean s ( p =0.004) (Table 3). Height: The mean ± D scar height pre treatment of Group A was 1.66±0.48 and that post treatment was 1.06±0.25. The mean difference between pre and post treatment was 0.6 and the percent of change was 36.14%. There was a significant decrease in the mean s (p=0.0001). The mean ± D scar height pre treatment of Group B was 1.93±0.79 and that post treatment was 1.46 ±0.51. The mean difference between pre and post treatment was 0.47 and the percent of change was 24.35%. There was a significant decrease in the mean s (p=0.01) (Table 3). Table (3): Paired t-test for comparison between pre and post treatment mean s of modified vancouver scar assessment scale of both Group (A & B). Modified vancouver scar assessment scale Pre Post MD % of change t- p - ig. Pliability: Group A 2.13± ± Group B 2± ± Height: Group A 1.66± ± Group B 1.93± ± Vascularity: Group A 2.53± ± Group B 2.6±0.5 2±
4 66 Contractubex Versus Corticosteroid Phonophoresis on Burn Hypertrophic car Vascularity: The mean ± D scar vascularity pre treatment of Group A was 2.53 ±0.51 and that post treatment was 1.4±0.5. The mean difference between pre and post treatment was 1.13 and the percent of change was 44.66%. There was a significant decrease in the mean s ( p=0.0001). The mean ± D scar vascularity pre treatment of Group B was 2.6 ±0.5 and that post treatment was 2±0.65. The mean difference between pre and post treatment was 0.6 and the percent of change was 23.07%. There was a significant decrease in the mean s ( p=0.0001) (Table 3). Table (4): Unpaired t-test for comparison between post treatments mean s of modified vancouver scar assessment scale of both Group (A & B). Vancouver scar assessment scale Group A Group B MD t- p- ig. Pliability Height Vascularity 1.13± ± ± ± ±0.51 2± Discussion There are many factors which may contribute to scar overgrowth, including ethnicity, other genetic influences anatomical region affected, wound depth, injury type, presence of infection and prolonged immune responses. Evidently for some predisposed individuals, healing processes may produce excessive wound matrix which causes itching and pain [8]. The most interesting results of the current study was the presence of high significance difference and improvement of all scores, mean s and percent of change of scar pliability, height and vascularity before and after treatment with contractubex phonophoresis group compared to triamcenolone phonophoresis group after completion of sessions. In a double-blind study, the researchers concluded that onions have pharmacologically active ingredients that exhibit anti-inflammatory and/or antiallergic properties. In a 6-month study, researchers evaluated the ability of scar-specific contractubex gel which contains 10% onion extract, as well as sodium heparin and 1% allantoin, another botanical product to contribute to scar development in children who underwent thoracic surgery. The increase in scar size was significantly smaller in treated patients than in untreated patients, and treated scars exhibited quicker lightening. In addition, physiologic scars developed into hypertrophic or keloidal scars more frequently in the untreated group. Contractubex was well tolerated, and its effects persisted through the 6-month follow-up visit [9]. Dr. D.-J. Danneberg, surgeon in his own medical practice in Lampertheim (Germany), presented the results of a study investigating the effect of the combination of contractubex treatment with therapeutic ultrasound. Danneberg concluded that the combination of contractubex with the physical method of ultrasound is an effective and well tolerated method to improve the results of the therapy of hypertrophic scars [10]. Contractubex treatment of hypertrophic scars in the routine clinical setting was compared to local/intralesional corticosteroid treatment. At the end of the per protocol treatment, 42.5% (study group) and 22.2% (control group), respectively, of the patients showed a normalization of pretreatment pathological primary aims (erythema, pruritus, consistency of hypertrophic scars), and confirmed the statistically significant superiority of the contractubex treatment as compared to corticosteroid treatment. The time to normalization was significantly lower for patients treated with contractubex than for patients treated with corticosteroids [11]. In studies by Nedelec et al., the vancouver scar scale was used to rate skin graft donor site and burn scars. The reliability of the overall scores and of individual parameters was found to be lower than required for a reliable assessment [12]. A pneumatonometer used by ophthalmologists has been applied to measure burn scars. The results correlated well with the subjective assessment made with the V pliability subscale, but there have been no reports of the reliability of the method. In the study by Oliveira et al., it showed correlation with the subjective assessment and measurements made with a pneumatonometer in burn scar assessment. However, the authors did not investigate the reliability of the method [13].
5 Wafaa H. Borhan, et al. 67 At the end, the results of this study showed that there were improvements in Group A than Group B, so these results were rejecting the hypothesis as there was no difference between the effects of contractubex and corticosteroid phonophoresis on hypertrophic scar after thermal burn. Conclusion: Contractubex phonophoresis, described in this study for hypertrophic scar after thermal burn, is more effective in improving pliability, height and vascularity of hypertrophic scar than corticosteroid triamcinolone phonophoresis. References 1- BRIAN BERMAN, OLIVER A. PEREZ, AILEH KON- DA, BRUCE E. KOHUT, MARTHA H. VIERA, U- ZETTE DELGADO, DEBORAH ZELL and QING L.I.: A Review of the Biologic Effects, Clinical Efficacy, and afety of ilicone Elastomer heeting for Hypertrophic and Keloid car Treatment and Management. Dermatol. urg., 33: , GERD G. GAUGLITZ, HAN C. KORTING, TATIANA PAVICIC, THOMA RUZICKA and MARC G. JECH- KE: Hypertrophic carring and Keloids: Pathomechanisms and Current and Emerging Treatment trategies. Mol. Med., (17) (1-2): , ENGRAV H. LOREN, GARNER L. WARREN and TREDGET E EDWARD: Hypertrophic cars. Journal of Burn Care & Research, 28: (4), CHÁVEZ J.J., MARTÍNEZ B.D., VILLEGA- GONZÁLEZ A.M., RODRÍGUEZ-CRUZ M.I. and DOMÍNGUEZ-DELGADO L.C.: "The use of onophoresis in the Administration of drugs throughout the skin." J. Pharm. Pharmaceut. ci., 12 (1): , AHIN M.T., INAN., OZTURKCAN., GUZEL E., BILAC C., GIRAY G. and MUFTUOGLU.: Comparison of the Effects of Contractubex Gel in an Experimental Model of car Formation in Rats: an immunohistochemical and ultrastructural study. J. Drugs Dermatol., 1: 74-81, ROCKWELL W.B., COHEN I.K. and EHRLICH H.P.: Keloid and Hypertrophic cars. A comprehensive review. Plast. Recontr. urg., 84 (5): , EL-HAKEEM M.., NOAIR A.A., ELHARKAWY G. A., and TAWFIK E.: Therapeutic Results of Corticosteroids Phonophoresis on Post-Burn Hypertrophic cars Master thesis, Faculty of Physical Therapy, MAHNOUH MOMENI, FARHAD HAFEZI, HOEIN RAHBAR and HAMID KARIMI: Effects of ilicone Gel on Burn cars. Burns, 35: 70-4, AUMANN. LELIE: Onion Extract. Elsevier, (36) 8: 25, MULLER. HELMET: About cars, carring and Treatment options. Blackwell Dermatology News, 8: 1-4, BEUTH J., HUNZELMANN N., VAN LEENDERT R., BATEN R., NOEHLE M. and CHNEIDER B.: afety and Efficacy of Local Administration of Contractubex to Hypertrophic cars in Comparison to Corticosteroid Treatment. Results of a Multicenter, Comparative Epidemiological Cohort tudy in Germany. In vivo, 20: , NEDELEC B., CORREA J.A., RACHELKA G., AR- MOUR A. and LAALLE L.: Quantitative Measurement of Hypertrophic car: Intrarater Reliability, ensitivity, and pecificity. J. Burn Care Res., 29: , OLIVEIRA G.V., CHINKE D., MITCHELL C., OLIV- ERA G., HAWKIN H.K. and HERNDON D.N.: Objective Assessment of Burn car Vascularity, Erythema, Pliability, Thickness, and Planimetry. Dermatol. urg., (31): 48-58, 2005.
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