Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: Study protocol for a randomised controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Bijlard, Eveline ^a   Timman, Reinier ^a   Verduijn, Gerda M ^a   Niessen, Frank B ^b   van Neck, Johan W ^a   Busschbach, Jan J V ^a   Mureau, Marc A M ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Brachytherapy; Corticosteroids; Cryotherapy; Keloid; POSAS; Quality of life; RCT; SF36; Skindex 29

Indexed keywords

TRIAMCINOLONE ACETONIDE;

ADULT; AGED; ARTICLE; BRACHYTHERAPY; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; CRYOTHERAPY; EXCISION; HUMAN; INTERMETHOD COMPARISON; KELOID; MAJOR CLINICAL STUDY; MIDDLE AGED; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PATIENT AND OBSERVER SCAR ASSESSMENT SCALE; POSTOPERATIVE PERIOD; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; SHORT FORM 36; SKINDEX 29; TREATMENT OUTCOME; YOUNG ADULT;

ADRENAL CORTEX HORMONES; BRACHYTHERAPY; CICATRIX; CLINICAL PROTOCOLS; CRYOTHERAPY; HUMANS; INJECTIONS, INTRALESIONAL; KELOID; LINEAR MODELS; NETHERLANDS; QUALITY OF LIFE; QUESTIONNAIRES; RECURRENCE; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84890365530     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-439     Document Type: Article

References (39)

1. Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: a review. Plast Reconstr Surg 1999, 104:1435-1458. 10.1097/00006534-199910000-00031, 10513931.
2. Brown BC, McKenna SP, Siddhi K, McGrouther DA, Bayat A. The hidden cost of skin scars: quality of life after skin scarring. J Plast Reconstr Aesthet Surg 2008, 61:1049-1058. 10.1016/j.bjps.2008.03.020, 18617450.
3. Cohen IK, Beaven MA, Horáková Z, Keizer HR. Histamine and collagen synthesis in keloid and hypertrophic scar. Surg Forum 1972, 23:509-510.
4. Cohen IK, Keizer HR, Sjoerdsma A. Collagen synthesis in human keloid and hypertrophic scar. Surg Forum 1971, 22:488-489.
5. Syed F, Ahmadi E, Iqbal SA, Singh S, McGrouther DA, Bayat A. Fibroblasts from the growing margin of keloid scars produce higher levels of collagen I and III compared with intralesional and extralesional sites: clinical implications for lesional site-directed therapy. Br J Dermatol 2011, 164:83-96. 10.1111/j.1365-2133.2010.10048.x, 20849516.
6. Uitto J, Perejda AJ, Abergel RP, Chu ML, Ramirez F. Altered steady-state ratio of type I/III procollagen mRNAs correlates with selectively increased type I procollagen biosynthesis in cultured keloid fibroblasts. Proc Natl Acad Sci U S A 1985, 82:5935-5939. 10.1073/pnas.82.17.5935, 390668, 3862108.
7. Abergel RP, Pizzurro D, Meeker CA, Lask G, Matsuoka LY, Minor RR, Chu ML, Uitto J. Biochemical composition of the connective tissue in keloids and analysis of collagen metabolism in keloid fibroblast cultures. J Investig Dermatol 1985, 84:384-390. 10.1111/1523-1747.ep12265471, 3998489.
8. Wolfram D, Tzankov A, Pulzl P, Piza-Katzer H. Hypertrophic scars and keloids - A review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg 2009, 35:171-181. 10.1111/j.1524-4725.2008.34406.x, 19215252.
9. Ogawa R. Mechanobiology of scarring. Wound Repair Regen 2011, 19(Suppl 1):s2-s9.
10. Shih B, Bayat A. Genetics of keloid scarring. Arch Dermatol Res 2010, 302:319-339. 10.1007/s00403-009-1014-y, 20130896.
11. Bran GM, Goessler UR, Hormann K, Riedel F, Sadick H. Keloids: current concepts of pathogenesis (review). Int J Mol Med 2009, 24:283-293.
12. Lim IJ, Phan TT, Bay BH, Huynh H, Tan WT, Lee ST, Longaker MT. Fibroblasts cocultured with keloid keratinocytes: normal fibroblasts secrete collagen in a keloidlike manner. Am J Physiol Cell Physiol 2002, 283:C212-C222. 10.1152/ajpcell.00555.2001, 12055090.
13. Seifert O, Mrowietz U. Keloid scarring: bench and bedside. Arch Dermatol Res 2009, 301:259-272. 10.1007/s00403-009-0952-8, 19360429.
14. Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE. International clinical recommendations on scar management. Plast Reconstr Surg 2002, 110:560-571. 10.1097/00006534-200208000-00031, 12142678.
15. Ud-Din S, Bayat A. Strategic management of keloid disease in ethnic skin: a structured approach supported by the emerging literature. Br J Dermatol 2013, 169:71-81.
16. Tan E, Chua SH, Lim JTE. Topical silicone gel sheet versus intralesional injections of triamcinolone acetonide in the treatment of keloids - a patient-controlled comparative clinical trial. J Dermatol Treat 1999, 10:251-254.
17. Niessen FB, Spauwen PH, Robinson PH, Fidler V, Kon M. The use of silicone occlusive sheeting (Sil-K) and silicone occlusive gel (Epiderm) in the prevention of hypertrophic scar formation. Plast Reconstr Surg 1998, 102:1962-1972. 10.1097/00006534-199811000-00023, 9810992.
18. Lawrence WT. In search of the optimal treatment of keloids: report of a series and a review of the literature. Ann Plast Surg 1991, 27:164-178. 10.1097/00000637-199108000-00012, 1835334.
19. Har-Shai Y, Amar M, Sabo E. Intralesional cryotherapy for enhancing the involution of hypertrophic scars and keloids. Plast Reconstr Surg 2003, 111:1841-1852. 10.1097/01.PRS.0000056868.42679.05, 12711943.
20. Har-Shai Y, Brown W, Labbe D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study. Int J Low Extrem Wounds 2008, 7:169-175. 10.1177/1534734608322813, 18757392.
21. Har-Shai Y, Sabo E, Rohde E, Hyams M, Assaf C, Zouboulis CC. Intralesional cryosurgery enhances the involution of recalcitrant auricular keloids: a new clinical approach supported by experimental studies. Wound Repair Regen 2006, 14:18-27. 10.1111/j.1524-475X.2005.00084.x, 16476068.
22. Furtado F, Hochman B, Ferreira LM. Evaluating keloid recurrence after surgical excision with prospective longitudinal scar assessment scales. J Plast Reconstr Aesthet Surg 2012, 65:e175-e181. 10.1016/j.bjps.2012.02.005, 22386498.
23. * brachytherapy: a retrospective study. J Eur Acad Dermatol Venereol 2009, 23:807-813. 10.1111/j.1468-3083.2009.03190.x, 19470053.
24. Kal HB, Veen RE, Jurgenliemk-Schulz IM. Dose-effect relationships for recurrence of keloid and pterygium after surgery and radiotherapy. Int J Radiat Oncol Biol Phys 2009, 74:245-251. 10.1016/j.ijrobp.2008.12.066, 19362243.
25. van de Kar AL, Kreulen M, van Zuijlen PP, Oldenburger F. The results of surgical excision and adjuvant irradiation for therapy-resistant keloids: a prospective clinical outcome study. Plast Reconstr Surg 2007, 119:2248-2254. 10.1097/01.prs.0000260751.20217.28, 17519728.
26. Van De Kar AL, Corion LUM, Smeulders MJC, Draaijers LJ, Van Der Horst CMAM, Van Zuijlen PPM. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg 2005, 116:514-522. 10.1097/01.prs.0000172982.43599.d6, 16079683.
27. Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg 2007, 119:487-494. 10.1097/01.prs.0000252949.77525.bc, 17230080.
28. Nicholas RS, Falvey H, Lemonas P, Damodaran G, Ghannem A, Selim F, Navsaria H, Myers S. Patient-related keloid scar assessment and outcome measures. Plast Reconstr Surg 2012, 129:648-656. 10.1097/PRS.0b013e3182402c51, 22373972.
29. Lindeboom JA, van Coppenraet ESB, Kuijper EJ, Polsbroek RM, Horsthuis RB, Prins JM, Lindeboom R. Interpretation and precision of the Observer Scar Assessment Scale improved by a revised scoring. J Clin Epidemiol 2008, 61:1289-1295. 10.1016/j.jclinepi.2008.04.001, 18619791.
30. Both H, Essink-Bot M-L, Busschbach J, Nijsten T. Critical review of generic and dermatology-specific health-related quality of life instruments. J Investig Dermatol 2007, 127:2726-2739. 10.1038/sj.jid.5701142, 17989733.
31. Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol 1997, 133:1433-1440. 10.1001/archderm.1997.03890470111018, 9371029.
32. Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS?. BMJ 1993, 306:1440-1444. 10.1136/bmj.306.6890.1440, 1677883, 8518640.
33. Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MA, te Velde A, Verrips E. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol 1998, 51:1055-1068. 10.1016/S0895-4356(98)00097-3, 9817123.
34. Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data 2000, New York: Springer.
35. Verbeke G, Molenberghs G. Liniair Mixed Models in Practice - A SAS Oriented Approach 1997, New York: Springer.
36. Singer JDWJ. Applied Longitudinal Data Analysis - Modeling Change and Event Occurrence 2003, Oxford: Oxford University Press, 1.
37. Little RJA, Rubin DB. Statistical Analysis with Missing Data 1987, New York: John Wiley and Sons.
38. Cohen J. A power primer. Psychol Bull 1992, 112:155-159.
39. Aberson CL. Applied Power Analysis for the Behavioral Sciences 2012, New York: Routledge.