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Delayed recruitment
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| Name | Class |
|---|---|
| Synedgen, Inc. | INDUSTRY |
| United States Department of Defense | FED |
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This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited form the UPMC Mercy Burn Center adult patient pool who have sustained superficial partial-thickness burn wounds that comprise less than or equal to 10% of total body surface area (TBSA)
Current effective dressings for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver sulfadiazine | Active Comparator | 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. |
|
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days to Healing of the Superficial Partial Thickness Burn Wound. | Number of days to healed burn wound (re-epithelialization as defined by greater than or equal to 90% epithelialized wound, determined by investigator exam and review of wound photographs, as needed) | up to 21 days |
| Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score | The patient and observer scar assessment scale (POSAS) is used to measure scar quality. It is composed of a patient reported section and an observer reported section (6 scored items each). Each section consists of items on a ten-step scale (1= as normal skin to 10=very different from normal skin/worst scar imaginable). A higher score indicates more symptoms/issues present; the lower the score the closer to normal skin. These sections are then summed together to make up the total score (maximum of 120 and minimum of 12). Please note the means listed denote the difference in POSAS score between the baseline and last assessment completed (21 days if last visit completed, or earlier visit if withdrawn or lost to follow up). | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety- Infection Rate From Screening Visit to Visit 8 | Safety as measured by total incidences of infection from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn. | up to 21 days |
| Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Peter Rubin, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16614255 | Background | 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. | |
| 26724539 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Please see participant flow for details of subject withdraw and lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days to Healing of the Superficial Partial Thickness Burn Wound. | Number of days to healed burn wound (re-epithelialization as defined by greater than or equal to 90% epithelialized wound, determined by investigator exam and review of wound photographs, as needed) | 23 subjects completed the study. Two subjects in the SynePure+ Catasyn group were lost-to-follow-up, and one subject in the silver sulfadiazine group withdrew due to an adverse reaction. Additionally, one subject missed three study visits (37.5% of visits) but did complete the first and final visits, so the primary outcomes were still available. All 26 subjects received at least one treatment and were included in the intention-to-treat analysis. | Posted | Median | Full Range | Days to healing | up to 21 days |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burn to left shoulder | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eleanor Shirley, MA CCRC | University of Pittsburgh | 412-383-7712 | shirleye@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 20, 2022 | Nov 2, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D012837 | Silver Sulfadiazine |
| ID | Term |
|---|---|
| D013411 | Sulfadiazine |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
Not provided
Not provided
This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group).
Not provided
Not provided
Not provided
Not provided
|
| Silver Sulfadiazine | Drug | Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds. |
|
|
Safety as measured by total incidence of progression of burn wounds to deep partial thickness/full thickness from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn. |
| up to 21 days |
| Safety- Rate of Complications From Screening Visit to Visit 8 | Safety as measured by rate of adverse event/complication that resulted in a change to the participant's treatment course from initial standard of care from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn. | up to 21 days |
| Safety- as Measured by Change in Total Vancouver Scar Scale Score From Screening Visit to Visit 8, or to Last Visit Completed, for the Three Lost to Follow up Participants, and 1 Participant Who Was Withdrawn. | Vancouver Scar Scale Score: The VSS is a scale to assess the extent of scarring for a given wound by scoring the pigmentation, vascularity, pliability and height of the scar. Each domain is individually scored then the domains are summed to give a total score that range from zero (0) to 13 with zero (0) representing a 'normal' presentation. Validity and reliability of the scale have been documented and is commonly used in wound healing research. The means listed represent the difference in total score from baseline to 21 days, or from baseline to last assessment, if participant did not complete the 21 day visit. | up to 21 days |
| 22030441 | Background | 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. |
| 29901799 | Background | 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. |
| 23740764 | Background | 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. |
| 26173045 | Background | Wasiak J, Cleland H. Burns: dressings. BMJ Clin Evid. 2015 Jul 14;2015:1903. |
| 29342216 | Background | 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. |
| 30123191 | Background | 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. |
| 2373734 | Background | 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. |
| 15720096 | Background | 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. |
| 14636751 | Background | 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. |
| 8537427 | Background | 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. |
| Background | Maruish M. User's manual for the SF-12v2 Health Survey. 3. Lincoln, RI: QualityMetric Inc.; 2012. |
| 19424821 | Background | 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. |
| 15253184 | Background | 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. |
| 16079683 | Background | 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. |
| 29180591 | Background | 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. |
| 28742235 | Background | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The patient and observer scar assessment scale (POSAS) | The patient and observer scar assessment scale (POSAS) is used to measure scar quality. It is composed of a patient reported section and an observer reported section (6 scored items each). Each section consists of items on a ten-step scale (1= as normal skin to 10=very different from normal skin/worst scar imaginable). A higher score indicates more symptoms/issues present; the lower the score the closer to normal skin. These are then summed together to make up the total score (maximum of 120 and minimum of 12). | Mean | Full Range | Mean Total POSAS Baseline Score |
|
| OG001 | 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. |
|
|
| Primary | Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score | The patient and observer scar assessment scale (POSAS) is used to measure scar quality. It is composed of a patient reported section and an observer reported section (6 scored items each). Each section consists of items on a ten-step scale (1= as normal skin to 10=very different from normal skin/worst scar imaginable). A higher score indicates more symptoms/issues present; the lower the score the closer to normal skin. These sections are then summed together to make up the total score (maximum of 120 and minimum of 12). Please note the means listed denote the difference in POSAS score between the baseline and last assessment completed (21 days if last visit completed, or earlier visit if withdrawn or lost to follow up). | The sample size was too small to perform the planned analysis with confidence that the results are valid and represent the population (total n = 26, n = 13 per group). | Posted | Mean | Standard Deviation | score on a scale | up to 21 days |
|
|
|
| Secondary | Safety- Infection Rate From Screening Visit to Visit 8 | Safety as measured by total incidences of infection from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn. | The sample size was too small to perform the planned analysis with confidence that the results are valid and represent the population (total n = 26, n = 13 per group). | Posted | Count of Participants | Participants | up to 21 days |
|
|
|
| Secondary | Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8 | Safety as measured by total incidence of progression of burn wounds to deep partial thickness/full thickness from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn. | The sample size was too small to perform the planned analysis with confidence that the results are valid and represent the population (total n = 26, n = 13 per group). | Posted | Count of Participants | Participants | up to 21 days |
|
|
|
| Secondary | Safety- Rate of Complications From Screening Visit to Visit 8 | Safety as measured by rate of adverse event/complication that resulted in a change to the participant's treatment course from initial standard of care from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn. | The sample size was too small to perform the planned analysis with confidence that the results are valid and represent the population (total n = 26, n = 13 per group). | Posted | Count of Participants | Participants | up to 21 days |
|
|
|
| Secondary | Safety- as Measured by Change in Total Vancouver Scar Scale Score From Screening Visit to Visit 8, or to Last Visit Completed, for the Three Lost to Follow up Participants, and 1 Participant Who Was Withdrawn. | Vancouver Scar Scale Score: The VSS is a scale to assess the extent of scarring for a given wound by scoring the pigmentation, vascularity, pliability and height of the scar. Each domain is individually scored then the domains are summed to give a total score that range from zero (0) to 13 with zero (0) representing a 'normal' presentation. Validity and reliability of the scale have been documented and is commonly used in wound healing research. The means listed represent the difference in total score from baseline to 21 days, or from baseline to last assessment, if participant did not complete the 21 day visit. | The sample size was too small to perform the planned analysis with confidence that the results are valid and represent the population (total n = 26, n = 13 per group). | Posted | Mean | Standard Deviation | score on a scale | up to 21 days |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 4 |
| 13 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 4 | 13 |
|
| Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Dermal budding | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Limb swelling | Blood and lymphatic system disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| pain (burning/stinging) | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Parathesis, tingling | Nervous system disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Warmth | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| headache | General disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Sinusitis | General disorders | Systematic Assessment | Mild, unrelated to study procedure or product. |
|
| Skin rash, allergic reaction | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, probably related to study product (silver sulfadiazine). Per PI, subject was withdrawn from the study. |
|
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |