CLINICAL STUDY ON TOPICAL Bismuth Subgallate/Borneol (SuileTM) DRESSING FOR TREATMENT OF DIABETIC FOOT ULCERS_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

WANG Fang ¹ , YUAN Nanbing ^1# , WANG Yuzhen ² , WANG Chun ¹ , WANG Aihong ² , YU Tingting ¹ , LIU Guanjian ³ , XU Zhangrong ² , RAN Xingwu ¹

1Diabetic Foot Care Center, Department of Endocrinology, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China;;
2Department of Endocrinology, No.306 Hospital of Chinese PLA;;
3Chinese Evidence-Based Medicine /Cochrance Centre. Corresponding author: RAN Xingwu, E-mail: ranxingwu@yahoo.com.cn;;
XU Zhangrong, E-mail: xzr1021@vip.sina.com;

Corresponding author：

Keywords：

Bismuth Subgallate/Borneol (SuileTM); Intrasite gel; Diabetic foot ulcer; Randomized controlled trial

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Objective To evaluate the efficacy and safety of Bismuth Subgallate/Borneol (SuileTM) (BSB) dressing in the treatment of diabetic foot ulcers. Method s A two-center, randomized controlled parallel-group comparison study was conducted. Between September 2005 and November 2006, 35 patients with nonhealing diabetic foot ulcer (Wagner 2-3 grade) were recruited and divided randomly into the test group (BSB group, n=25) and control group (IG group, n=10). There was no significant difference in general data between 2 groups (P gt; 0.05). Based on the comprehensive therapy of diabetic foot, ulcers were topically treated by SuileTM dressing and Intrasite gel in the BSB group and IG group, respectively. The ulcer area was measured once a week. Ulcer bleeding was observed and acceptance of the dressing was inquired each week. Results Of the patients, 22 patients in the BSB group and 8 in the IG group completed the clinical trial. Intention to treat (ITT) analysis indicated that the results were excellent in 19 (76%) cases, good in 3 cases (12%), fair in 1 case (4%), and poor in 2 cases (8%) in the BSB group. In the IG group, the results were excellent in 8 cases (80%) cases, fair in 1 case (10%), and poor in 1 case (10%). Per-protocol (PP) analysis showed that the results were excellent in 19 cases (86%) and good in 3 cases (14%) in the BSB group, and were excellent in 8 cases (100%) in the IG group. The results of ITT and PP analysis all showed no significant difference between 2 groups (P gt; 0.05). The change trend of ulcer areas in the BSB group was similar to that in the IG group. There was no significant difference in the hemostatic effect between 2 groups (P gt; 0.05) and the patients were more likely to accept BSB dressings. Conclusion BSB dressings is an effective, safe, and generally well-tolerated therapy dressing in the treatment of diabetic foot ulcers.

Citation： WANG Fang,YUAN Nanbing,WANG Yuzhen,WANG Chun,WANG Aihong,YU Tingting,LIU Guanjian,XU Zhangrong,RAN Xingwu. CLINICAL STUDY ON TOPICAL Bismuth Subgallate/Borneol (SuileTM) DRESSING FOR TREATMENT OF DIABETIC FOOT ULCERS. Chinese Journal of Reparative and Reconstructive Surgery, 2012, 26(8): 955-960. doi: Copy

1.	何利平, 冉兴无. 糖尿病足的诊治进展. 内科急危重症杂志, 2008, 14(4): 171-173, 183.
2.	Bloomgarden ZT. The diabetic foot. Diabetes Care, 2008, 31(2): 372-376.
3.	Mai LM, Lin CY, Chen CY, et al. Synergistic effect of bismuth subgallate and borneol, the major components of Sulbogin, on the healing of skin wound. Biomaterials, 2003, 24(18): 3005-3012.
4.	Tramontina VA, Machado MA, Nogueira Filho Gda R, et al. Effect of bismuth subgallate (local hemostatic agent) on wound healing in rats: Histological and histometric findings. Braz Dent J, 2002, 13(1): 11-16.
5.	Fenton JE, Blayney AW, O’Dwyer TP, et al. Bismuth subgallate—its role in tonsillectomy. J Laryngol Otol, 1995, 109(3): 203-205.
6.	Callanan V, Curran AJ, Smyth DA, et al. The influence of bismuth subgallate and adrenaline paste upon operating time and operative blood loss in tonsillectomy. J Laryngol Otol, 1995, 109(3): 206-208.
7.	Scanlon L. Review: debridement using hydrogel appears to be more effective than standard wound care for healing diabetic foot ulcers. Evid Based Nurs, 2003, 6(3): 83.
8.	Ingle R, Levin J, Polinder K. Wound healing with honey—a randomised controlled trial. S Afr Med J, 2006, 96(9): 831-835.
9.	Rook JM, Hasan W, McCarson KE. Temporal effects of topical morphine application on cutaneous wound healing. Anesthesiology, 2008, 109(1): 130-136.
10.	王艳, 刘关键, 袁南兵, 等. 数码照相结合Image J 医学图像分析软件法与无菌薄膜勾边法测量糖尿病皮肤溃疡面积的可靠性比较. 中国修复重建外科杂志, 2008, 22(5): 563-566.
11.	姜小飞, 冉兴无. 糖尿病足溃疡面积及体积计算的方法学介绍. 华西医学, 2008, 23(1): 114-115.
12.	袁南兵, 王椿, 王艳, 等. 自体富血小板凝胶在糖尿病难治性皮肤溃疡中的初步应用. 四川大学学报: 医学版, 2007, 38(5): 900-903.
13.	Dharmananda S. Borneol, artemisia, and moxa[EB/OL]. [1998-09-01]. http: //www. itmonline. org /arts/ borneol. htm.
14.	Serena T, Parnall LK, Knox C, et al. Bismuth subgallate/borneol (suile) is superior to bacitracin in the human forearm biopsy model for acute wound healing. Adv Skin Wound Care, 2007, 20(9 Pt 1): 485-492.
15.	Uchi H, Igarashi A, Urabe K, et al. Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer. Eur J Dermatol, 2009, 19(5): 461-468.
16.	Blozik E, Scherer M. Skin replacement therapies for diabetic foot ulcers: systematic review and meta-analysis. Diabetes Care, 2008, 31(4): 693-694.
17.	Langer A, Rogowski W. Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers. BMC Health Serv Res, 2009, 9: 115.
18.	Jeffcoate WJ, Price PE, Phillips CJ, et al. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technol Assess, 2009, 13(54): 1-86.
19.	Biswas A, Bharara M, Hurst C, et al. Use of sugar on the healing of diabetic ulcers: a review. J Diabetes Sci Technol, 2010, 4(5): 1139-1145.
20.	Eddy JJ, Gideonsen MD, Mack GP. Practical considerations of using topical honey for neuropathic diabetic foot ulcers: a review. WMJ, 2008, 107(4): 187-190.
21.	Viswanathan V, Kesavan R, Kavitha KV, et al. A pilot study on the effects of a polyherbal formulation cream on diabetic foot ulcers. Indian J Med Res, 2011, (134): 168-173.

1. 何利平, 冉兴无. 糖尿病足的诊治进展. 内科急危重症杂志, 2008, 14(4): 171-173, 183.
2. Bloomgarden ZT. The diabetic foot. Diabetes Care, 2008, 31(2): 372-376.
3. Mai LM, Lin CY, Chen CY, et al. Synergistic effect of bismuth subgallate and borneol, the major components of Sulbogin, on the healing of skin wound. Biomaterials, 2003, 24(18): 3005-3012.
4. Tramontina VA, Machado MA, Nogueira Filho Gda R, et al. Effect of bismuth subgallate (local hemostatic agent) on wound healing in rats: Histological and histometric findings. Braz Dent J, 2002, 13(1): 11-16.
5. Fenton JE, Blayney AW, O’Dwyer TP, et al. Bismuth subgallate—its role in tonsillectomy. J Laryngol Otol, 1995, 109(3): 203-205.
6. Callanan V, Curran AJ, Smyth DA, et al. The influence of bismuth subgallate and adrenaline paste upon operating time and operative blood loss in tonsillectomy. J Laryngol Otol, 1995, 109(3): 206-208.
7. Scanlon L. Review: debridement using hydrogel appears to be more effective than standard wound care for healing diabetic foot ulcers. Evid Based Nurs, 2003, 6(3): 83.
8. Ingle R, Levin J, Polinder K. Wound healing with honey—a randomised controlled trial. S Afr Med J, 2006, 96(9): 831-835.
9. Rook JM, Hasan W, McCarson KE. Temporal effects of topical morphine application on cutaneous wound healing. Anesthesiology, 2008, 109(1): 130-136.
10. 王艳, 刘关键, 袁南兵, 等. 数码照相结合Image J 医学图像分析软件法与无菌薄膜勾边法测量糖尿病皮肤溃疡面积的可靠性比较. 中国修复重建外科杂志, 2008, 22(5): 563-566.
11. 姜小飞, 冉兴无. 糖尿病足溃疡面积及体积计算的方法学介绍. 华西医学, 2008, 23(1): 114-115.
12. 袁南兵, 王椿, 王艳, 等. 自体富血小板凝胶在糖尿病难治性皮肤溃疡中的初步应用. 四川大学学报: 医学版, 2007, 38(5): 900-903.
13. Dharmananda S. Borneol, artemisia, and moxa[EB/OL]. [1998-09-01]. http: //www. itmonline. org /arts/ borneol. htm.
14. Serena T, Parnall LK, Knox C, et al. Bismuth subgallate/borneol (suile) is superior to bacitracin in the human forearm biopsy model for acute wound healing. Adv Skin Wound Care, 2007, 20(9 Pt 1): 485-492.
15. Uchi H, Igarashi A, Urabe K, et al. Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer. Eur J Dermatol, 2009, 19(5): 461-468.
16. Blozik E, Scherer M. Skin replacement therapies for diabetic foot ulcers: systematic review and meta-analysis. Diabetes Care, 2008, 31(4): 693-694.
17. Langer A, Rogowski W. Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers. BMC Health Serv Res, 2009, 9: 115.
18. Jeffcoate WJ, Price PE, Phillips CJ, et al. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technol Assess, 2009, 13(54): 1-86.
19. Biswas A, Bharara M, Hurst C, et al. Use of sugar on the healing of diabetic ulcers: a review. J Diabetes Sci Technol, 2010, 4(5): 1139-1145.
20. Eddy JJ, Gideonsen MD, Mack GP. Practical considerations of using topical honey for neuropathic diabetic foot ulcers: a review. WMJ, 2008, 107(4): 187-190.
21. Viswanathan V, Kesavan R, Kavitha KV, et al. A pilot study on the effects of a polyherbal formulation cream on diabetic foot ulcers. Indian J Med Res, 2011, (134): 168-173.

Chinese Journal of Reparative and Reconstructive Surgery

CLINICAL STUDY ON TOPICAL Bismuth Subgallate/Borneol (SuileTM) DRESSING FOR TREATMENT OF DIABETIC FOOT ULCERS

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