Study Summary
This trial will compare silicone tape to the current standard (no dressing) to see if it improves scar appearance after surgery.
Eligible Conditions
- Scarring
- Hypertrophic Scars
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 1 Secondary · Reporting Duration: 12 month follow up
12 month follow up
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Trial Safety
Trial Design
2 Treatment Groups
No dressing
1 of 2
Silicone tape
1 of 2
Active Control
Experimental Treatment
32 Total Participants · 2 Treatment Groups
Primary Treatment: Silicone tape · No Placebo Group · N/A
Silicone tape
Device
Experimental Group · 1 Intervention: Silicone tape · Intervention Types: DeviceNo dressingNoIntervention Group · 1 Intervention: No dressing · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month follow up
Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
242 Previous Clinical Trials
80,076 Total Patients Enrolled
2 Trials studying Scarring
116 Patients Enrolled for Scarring
Jason G Williams, MDPrincipal InvestigatorNova Scotia Health Authority
Eligibility Criteria
Age 18 - 65 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are having surgery to reshape your abdomen as part of your breast reconstruction.
References
- Meaume, Sylvie, Anne Le Pillouer-Prost, Bertrand Richert, Diane Roseeuw, and Javid Vadoud. 2014. “Management of Scars: Updated Practical Guidelines and Use of Silicones”. European Journal of Dermatology. John Libbey Eurotext. doi:10.1684/ejd.2014.2356.
- Gurtner, Geoffrey C., Sabine Werner, Yann Barrandon, and Michael T. Longaker. 2008. “Wound Repair and Regeneration”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature07039.
- Mustoe, Thomas A., Rodney D. Cooter, Michael H. Gold, F. D. Richard Hobbs, Albert-Adrien Ramelet, Peter G. Shakespeare, Maurizio Stella, Luc Téot, Fiona M. Wood, and Ulrich E. Ziegler. 2002. “International Clinical Recommendations on Scar Management”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00006534-200208000-00031.
- Hsu KC, Luan CW, Tsai YW. Review of Silicone Gel Sheeting and Silicone Gel for the Prevention of Hypertrophic Scars and Keloids. Wounds. 2017 May;29(5):154-158. Review.
- Truong, Pauline T., Junella C. Lee, Benjamin Soer, Catherine A. Gaul, and Ivo A. Olivotto. 2007. “Reliability and Validity Testing of the Patient and Observer Scar Assessment Scale in Evaluating Linear Scars After Breast Cancer Surgery”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000252949.77525.bc.
- Khoo, T.L., A.S. Halim, Z. Zakaria, A.Z. Mat Saad, L.Y. Wu, and H.Y. Lau. 2011. “A Prospective, Randomised, Double-blinded Trial to Study the Efficacy of Topical Tocotrienol in the Prevention of Hypertrophic Scars”. Journal of Plastic, Reconstructive & Aesthetic Surgery. Elsevier BV. doi:10.1016/j.bjps.2010.08.029.
- Duncan, Jonathan A. L., Jeremy S. Bond, Tracey Mason, Anna Ludlow, Peter Cridland, Sharon O???Kane, and Mark W. J. Ferguson. 2006. “Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality?”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000232378.88776.b0.
- Mustoe, Thomas A.. 2007. “Evolution of Silicone Therapy and Mechanism of Action in Scar Management”. Aesthetic Plastic Surgery. Springer Science and Business Media LLC. doi:10.1007/s00266-007-9030-9.
- Kappel, Stefani, Rebecca Kleinerman, Thomas H. King, Raja Sivamani, Sandra Taylor, UyenThao Nguyen, and Daniel B. Eisen. 2015. “Does Wound Eversion Improve Cosmetic Outcome?”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2014.11.032.
- Bleasdale, Benjamin, Simon Finnegan, Kathyryn Murray, Sean Kelly, and Steven L. Percival. 2015. “The Use of Silicone Adhesives for Scar Reduction”. Advances in Wound Care. Mary Ann Liebert Inc. doi:10.1089/wound.2015.0625.
- Draaijers, Lieneke J., Fenike R. H. Tempelman, Yvonne A. M. Botman, Wim E. Tuinebreijer, Esther Middelkoop, Robert W. Kreis, and Paul P. M. van Zuijlen. 2004. “The Patient and Observer Scar Assessment Scale: A Reliable and Feasible Tool for Scar Evaluation”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000122207.28773.56.
- Chen, Wei, Xiaobing Fu, Shili Ge, Tongzhu Sun, Gang Zhou, Duyin Jiang, and Zhiyong Sheng. 2005. “Ontogeny of Expression of Transforming Growth Factor-β and Its Receptors and Their Possible Relationship with Scarless Healing in Human Fetal Skin”. Wound Repair and Regeneration. Wiley. doi:10.1111/j.1067-1927.2005.130109.x.
- Finnerty, Celeste C, Marc G Jeschke, Ludwik K Branski, Juan P Barret, Peter Dziewulski, and David N Herndon. 2016. “Hypertrophic Scarring: The Greatest Unmet Challenge After Burn Injury”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(16)31406-4.
- van de Kar, Annekatrien L., Leonard U. M. Corion, Mark J. C. Smeulders, Lieneke J. Draaijers, Chantal M. A. M. van der Horst, and Paul P. M. van Zuijlen. 2005. “Reliable and Feasible Evaluation of Linear Scars by the Patient and Observer Scar Assessment Scale”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000172982.43599.d6.
- Joo, Jayne S., Anne R. Zhuang, Catherine Tchanque-Fossuo, Danielle Tartar, April W. Armstrong, Tom H. King, Raja K. Sivamani, and Daniel B. Eisen. 2019. “Dermal Suture Only Versus Layered Closure: A Randomized, Split Wound Comparative Effectiveness Trial”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2019.08.040.
- O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;(9):CD003826. doi: 10.1002/14651858.CD003826.pub3. Review.
- Longaker, Michael T., Rod J. Rohrich, Lauren Greenberg, Heather Furnas, Robert Wald, Vivek Bansal, Hisham Seify, et al.. 2014. “A Randomized Controlled Trial of the Embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/prs.0000000000000417.
- Sidgwick, G. P., D. McGeorge, and A. Bayat. 2015. “A Comprehensive Evidence-based Review on the Role of Topicals and Dressings in the Management of Skin Scarring”. Archives of Dermatological Research. Springer Science and Business Media LLC. doi:10.1007/s00403-015-1572-0.
- Bae, Seong Hwan, and Yong Chan Bae. 2014. “Analysis of Frequency of Use of Different Scar Assessment Scales Based on the Scar Condition and Treatment Method”. Archives of Plastic Surgery. Georg Thieme Verlag KG. doi:10.5999/aps.2014.41.2.111.
- Mustoe, Thomas A.. 2007. “Evolution of Silicone Therapy and Mechanism of Action in Scar Management”. Aesthetic Plastic Surgery. Springer Science and Business Media LLC. doi:10.1007/s00266-007-9030-9.
- Sidgwick, G. P., D. McGeorge, and A. Bayat. 2015. “A Comprehensive Evidence-based Review on the Role of Topicals and Dressings in the Management of Skin Scarring”. Archives of Dermatological Research. Springer Science and Business Media LLC. doi:10.1007/s00403-015-1572-0.
- Mustoe, Thomas A., Rodney D. Cooter, Michael H. Gold, F. D. Richard Hobbs, Albert-Adrien Ramelet, Peter G. Shakespeare, Maurizio Stella, Luc Téot, Fiona M. Wood, and Ulrich E. Ziegler. 2002. “International Clinical Recommendations on Scar Management”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00006534-200208000-00031.
- O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.
- Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.
- Hsu KC, Luan CW, Tsai YW. Review of Silicone Gel Sheeting and Silicone Gel for the Prevention of Hypertrophic Scars and Keloids. Wounds. 2017 May;29(5):154-158.
- 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 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.
- Finnerty CC, Jeschke MG, Branski LK, Barret JP, Dziewulski P, Herndon DN. Hypertrophic scarring: the greatest unmet challenge after burn injury. Lancet. 2016 Oct 1;388(10052):1427-1436. doi: 10.1016/S0140-6736(16)31406-4.
- Mustoe TA. Evolution of silicone therapy and mechanism of action in scar management. Aesthetic Plast Surg. 2008 Jan;32(1):82-92. doi: 10.1007/s00266-007-9030-9. Epub 2007 Oct 30.
- Bleasdale B, Finnegan S, Murray K, Kelly S, Percival SL. The Use of Silicone Adhesives for Scar Reduction. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):422-430. doi: 10.1089/wound.2015.0625.
- Sidgwick GP, McGeorge D, Bayat A. A comprehensive evidence-based review on the role of topicals and dressings in the management of skin scarring. Arch Dermatol Res. 2015 Aug;307(6):461-77. doi: 10.1007/s00403-015-1572-0. Epub 2015 Jun 5.
- Lorenz HP, Adzick NS. Scarless skin wound repair in the fetus. West J Med. 1993 Sep;159(3):350-5.
- van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
- Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.
- Meaume S, Le Pillouer-Prost A, Richert B, Roseeuw D, Vadoud J. Management of scars: updated practical guidelines and use of silicones. Eur J Dermatol. 2014 Jul-Aug;24(4):435-43. doi: 10.1684/ejd.2014.2356.
- Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Jason Williams 2020. "Silicone Taping for the Improvement of Abdominal Donor Site Scars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04506255.
Frequently Asked Questions
What are the criteria to be eligible for this clinical experiment?
"Those who seek to join this experiment must meet two qualifications: they need to have scarring and be between 18-65 years old. The team is attempting to enroll 32 participants in total." - Anonymous Online Contributor
Unverified Answer
Do you accept participants over 50 years old in this experiment?
"Patients between 18 and 65 years old are the only acceptable candidates for this clinical trial. However, there are 10 trials available to those below eighteen and 47 studies open to seniors above sixty-five." - Anonymous Online Contributor
Unverified Answer
How many participants are being granted access to this research?
"Affirmative. According to the records on clinicaltrials.gov, this research study is actively seeking participants; it first appeared online in November of 2020 and was recently modified on July 19th 2022. The investigation requires 32 patients from one location for enrolment." - Anonymous Online Contributor
Unverified Answer
Is this experiment still recruiting participants?
"According to clinicaltrials.gov, this research is presently engaging in participant recruitment. The trial was first publicized on November 16th 2020 and was last updated July 19th 2022." - Anonymous Online Contributor
Unverified Answer