Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
26 participants
INTERVENTIONAL
2021-06-11
2022-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Silver sulfadiazine
Topical management via dressings provide a barrier against microbial infection. The current gold standard for burn wound dressings is silver (nanoparticulate or ionic), and it has shown some efficacy in treating infections, but it does not demonstrate an ability to prevent infections and some treatment guidelines even recommend against its use. Although silver dressing is preferred for military use, a retrospective review spanning 10 years of use in military environments showed that silver was not more effective than other antimicrobial topical treatments, and a meta-analysis with over 2500 surgical patients found silver sulfadiazine was associated with increased infection rates and hospital length-of-stays were two days longer on average.
Silver Sulfadiazine
Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Synedgen has developed Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser. These products are Food and Drug Administration (FDA) 510(k) cleared wound care medical devices, formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure™ Wound Cleanser is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn™ Advanced Technology Hydrogel serves as a protective gel dressing. Together, these products reduce inflammation in wounds, aggregate bacteria and disrupt bacterial biofilms, and accelerate healing.
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Catasyn™ Advanced Technology Hydrogel is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing. SynePure™ Wound Cleanser is a non-cytotoxic wound cleanser for the removal of foreign material from epidermal and dermal wounds, burns, cuts, abrasions and minor irritations of the skin.
Interventions
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Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Catasyn™ Advanced Technology Hydrogel is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing. SynePure™ Wound Cleanser is a non-cytotoxic wound cleanser for the removal of foreign material from epidermal and dermal wounds, burns, cuts, abrasions and minor irritations of the skin.
Silver Sulfadiazine
Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older, male and female
* Patients who have sustained superficial, partial-thickness burn wounds ≤ to 10% of total body surface area (TBSA)
* Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment
Exclusion Criteria
* Deep partial-thickness burns and full-thickness burns
* Radiation, chemical, or electrical burn injury
* Patients with burns primarily located to the face, genitals, or span across joints
* Patients whose burn injury was ≥ to 48 hours prior to entry into the UPMC Mercy Burn Center Clinic.
* Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrine disease, hepatic disease, or renal disease; or other severe conditions for whom, in the physician investigators' discretion, would render study participation unsafe
* Patients with documented or self-reported shellfish allergies
* Current pregnancy
* Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion
* Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient
18 Years
ALL
No
Sponsors
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Synedgen, Inc.
INDUSTRY
United States Department of Defense
FED
J. Peter Rubin, MD
OTHER
Responsible Party
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J. Peter Rubin, MD
Endowed Chair of Plastic Surgery
Principal Investigators
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J. Peter Rubin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
Aurora A, Beasy A, Rizzo JA, Chung KK. The Use of a Silver-Nylon Dressing During Evacuation of Military Burn Casualties. J Burn Care Res. 2018 Jun 13;39(4):593-597. doi: 10.1093/jbcr/irx026.
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;2013(6):CD008738. doi: 10.1002/14651858.CD008738.pub2.
Wasiak J, Cleland H. Burns: dressings. BMJ Clin Evid. 2015 Jul 14;2015:1903.
Narayanaswamy VP, Giatpaiboon SA, Uhrig J, Orwin P, Wiesmann W, Baker SM, Townsend SM. In Vitro activity of novel glycopolymer against clinical isolates of multidrug-resistant Staphylococcus aureus. PLoS One. 2018 Jan 17;13(1):e0191522. doi: 10.1371/journal.pone.0191522. eCollection 2018.
Narayanaswamy VP, Keagy LL, Duris K, Wiesmann W, Loughran AJ, Townsend SM, Baker S. Novel Glycopolymer Eradicates Antibiotic- and CCCP-Induced Persister Cells in Pseudomonas aeruginosa. Front Microbiol. 2018 Aug 3;9:1724. doi: 10.3389/fmicb.2018.01724. eCollection 2018.
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.
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.
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.
Maruish M. User's manual for the SF-12v2 Health Survey. 3. Lincoln, RI: QualityMetric Inc.; 2012.
Cheak-Zamora NC, Wyrwich KW, McBride TD. Reliability and validity of the SF-12v2 in the medical expenditure panel survey. Qual Life Res. 2009 Aug;18(6):727-35. doi: 10.1007/s11136-009-9483-1. Epub 2009 May 8.
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.
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.
Elliott D; Bluebelle Study Group. Developing outcome measures assessing wound management and patient experience: a mixed methods study. BMJ Open. 2017 Nov 26;7(11):e016155. doi: 10.1136/bmjopen-2017-016155.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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STUDY20050205
Identifier Type: -
Identifier Source: org_study_id
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