Study Summary
This trial is comparing two burn wound treatments to see which is better. One group will use Silvadene and the other will use SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel.
Eligible Conditions
- Superficial Burns
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: up to 21 days
up to 21 days
Change from screening visit to visit 8 in total Patient and Observer Scar Assessment Scale (POSAS) score
Change from screening visit to visit 8, in healing of the superficial partial thickness burn wound
Safety- as measured by change in total Vancouver Scar Scale Score from screening visit to visit 8
Safety- infection rate from screening visit to visit 8
Safety- rate of complications from screening visit to visit 8
Safety- rate of noted wound progression from screening visit to visit 8
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Silver sulfadiazine
1 of 2
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
1 of 2
Active Control
Experimental Treatment
115 Total Participants · 2 Treatment Groups
Primary Treatment: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser · No Placebo Group · Phase 4
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Device
Experimental Group · 1 Intervention: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser · Intervention Types: DeviceSilver sulfadiazine
Drug
ActiveComparator Group · 1 Intervention: Silver Sulfadiazine · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 21 days
Who is running the clinical trial?
Synedgen, Inc.Industry Sponsor
United States Department of DefenseFED
779 Previous Clinical Trials
202,304 Total Patients Enrolled
Synedgen, IncUNKNOWN
J. Peter Rubin, MDLead Sponsor
3 Previous Clinical Trials
27 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to provide informed consent.
You are otherwise in good general physical and mental health.
You are 18 years of age or older, male or female.
References
- Church, Deirdre, Sameer Elsayed, Owen Reid, Brent Winston, and Robert Lindsay. 2006. “Burn Wound Infections”. Clinical Microbiology Reviews. American Society for Microbiology. doi:10.1128/cmr.19.2.403-434.2006.
- Narayanaswamy, Vidya P., Scott A. Giatpaiboon, John Uhrig, Paul Orwin, William Wiesmann, Shenda M. Baker, and Stacy M. Townsend. 2018. “In Vitro Activity of Novel Glycopolymer Against Clinical Isolates of Multidrug-resistant Staphylococcus Aureus”. Edited by Axel Cloeckaert. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0191522.
- Cheak-Zamora, Nancy C., Kathleen W. Wyrwich, and Timothy D. McBride. 2009. “Reliability and Validity of the Sf-12v2 in the Medical Expenditure Panel Survey”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-009-9483-1.
- 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.
- Barajas-Nava LA, López-Alcalde J, Roqué i Figuls M, Solà I, Bonfill Cosp X. Antibiotic prophylaxis for preventing burn wound infection. Cochrane Database Syst Rev. 2013 Jun 6;(6):CD008738. doi: 10.1002/14651858.CD008738.pub2. Review.
- Narayanaswamy, Vidya P., Laura L. Keagy, Kathryn Duris, William Wiesmann, Allister J. Loughran, Stacy M. Townsend, and Shenda Baker. 2018. “Novel Glycopolymer Eradicates Antibiotic- and Cccp-induced Persister Cells in Pseudomonas Aeruginosa”. Frontiers in Microbiology. Frontiers Media SA. doi:10.3389/fmicb.2018.01724.
- Baryza, Mary Jo, and Gregory A. Baryza. 1995. “The Vancouver Scar Scale: An Administration Tool and Its Interrater Reliability”. Journal of Burn Care & Rehabilitation. Oxford University Press (OUP). doi:10.1097/00004630-199509000-00013.
- Aziz, Z., S.F. Abu, and N.J. Chong. 2012. “A Systematic Review of Silver-containing Dressings and Topical Silver Agents (used with Dressings) for Burn Wounds”. Burns. Elsevier BV. doi:10.1016/j.burns.2011.09.020.
- Li-Tsang, Cecilia W.P, Joy C.M Lau, and Sally K.Y Liu. 2003. “Validation of an Objective Scar Pigmentation Measurement by Using a Spectrocolorimeter”. Burns. Elsevier BV. doi:10.1016/s0305-4179(03)00165-7.
- Durán, Nelson, Marcela Durán, Marcelo Bispo de Jesus, Amedea B. Seabra, Wagner J. Fávaro, and Gerson Nakazato. 2016. “Silver Nanoparticles: A New View on Mechanistic Aspects on Antimicrobial Activity”. Nanomedicine: Nanotechnology, Biology and Medicine. Elsevier BV. doi:10.1016/j.nano.2015.11.016.
- Aurora, Amit, Alexander Beasy, Julie A Rizzo, and Kevin K Chung. 2017. “The Use of a Silver–nylon Dressing During Evacuation of Military Burn Casualties”. Journal of Burn Care & Research. Oxford University Press (OUP). doi:10.1093/jbcr/irx026.
- 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.
- Wasiak J, Cleland H. Burns: dressings. BMJ Clin Evid. 2015 Jul 14;2015. pii: 1903. Review.
- Sullivan, T, J Smith, J Kermode, E Mclver, and D J Courtemanche. 1990. “Rating the Burn Scar”. Journal of Burn Care & Rehabilitation. Oxford University Press (OUP). doi:10.1097/00004630-199005000-00014.
- Elliott, Daisy. 2017. “Developing Outcome Measures Assessing Wound Management and Patient Experience: A Mixed Methods Study”. BMJ Open. BMJ. doi:10.1136/bmjopen-2017-016155.
- Oliveira, Gisele V., David Chinkes, Charles Mitchell, Gloria Oliveras, Hal K. Hawkins, and David N. Herndon. 2006. “Objective Assessment of Burn Scar Vascularity, Erythema, Pliability, Thickness, and Planimetry”. Dermatologic Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1524-4725.2005.31004.
- Nherera, Leo, Paul Trueman, Christopher Roberts, and Leena Berg. 2017. “Silver Delivery Approaches in the Management of Partial Thickness Burns: A Systematic Review and Indirect Treatment Comparison”. Wound Repair and Regeneration. Wiley. doi:10.1111/wrr.12559.
- Maruish M. User's manual for the SF-12v2 Health Survey. 3. Lincoln, RI: QualityMetric Inc.; 2012.
- Aziz Z, Abu SF, Chong NJ. A systematic review of silver-containing dressings and topical silver agents (used with dressings) for burn wounds. Burns. 2012 May;38(3):307-18. doi: 10.1016/j.burns.2011.09.020. Epub 2011 Oct 24.
- Wasiak J, Cleland H. Burns: dressings. BMJ Clin Evid. 2015 Jul 14;2015:1903.
- 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.
- Barajas-Nava LA, Lopez-Alcalde J, Roque i Figuls M, Sola I, Bonfill Cosp X. Antibiotic prophylaxis for preventing burn wound infection. Cochrane Database Syst Rev. 2013 Jun 6;(6):CD008738. doi: 10.1002/14651858.CD008738.pub2.
- Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.
- Oliveira GV, Chinkes D, Mitchell C, Oliveras G, Hawkins HK, Herndon DN. Objective assessment of burn scar vascularity, erythema, pliability, thickness, and planimetry. Dermatol Surg. 2005 Jan;31(1):48-58. doi: 10.1111/j.1524-4725.2005.31004.
- Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
- 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.
- Nherera L, Trueman P, Roberts C, Berg L. Silver delivery approaches in the management of partial thickness burns: A systematic review and indirect treatment comparison. Wound Repair Regen. 2017 Aug;25(4):707-721. doi: 10.1111/wrr.12559. Epub 2017 Aug 17.
- Li-Tsang CW, Lau JC, Liu SK. Validation of an objective scar pigmentation measurement by using a spectrocolorimeter. Burns. 2003 Dec;29(8):779-84. doi: 10.1016/s0305-4179(03)00165-7.
- Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
- Duran N, Duran M, de Jesus MB, Seabra AB, Favaro WJ, Nakazato G. Silver nanoparticles: A new view on mechanistic aspects on antimicrobial activity. Nanomedicine. 2016 Apr;12(3):789-799. doi: 10.1016/j.nano.2015.11.016. Epub 2015 Dec 24.
- J. Peter Rubin, MD 2021. "Superficial Partial-Thickness Burn Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04601532.
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