Superficial Partial Thickness Burn
Conditions
Brief summary
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)
Detailed description
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.
Interventions
DEVICECatasyn™ 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, a sulfa drug, is used to prevent and treat infections in burn wounds.
Sponsors
Synedgen, Inc.
United States Department of Defense
J. Peter Rubin, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide informed consent * 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
* Inability to provide informed consent * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Healing of the Superficial Partial Thickness Burn Wound. | up to 21 days | 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) |
| Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score | up to 21 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety- Infection Rate From Screening Visit to Visit 8 | up to 21 days | 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. |
| Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8 | up to 21 days | 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. |
| Safety- Rate of Complications From Screening Visit to Visit 8 | up to 21 days | 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. |
| 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. | up to 21 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawn due to allergic reaction to Silver sulfadiazine. | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Silver Sulfadiazine | Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 12 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 12 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 9 Participants | 9 Participants |
| Region of Enrollment United States | 26 participants | 13 participants | 13 participants |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 6 Participants |
| The patient and observer scar assessment scale (POSAS) | 64 Mean Total POSAS Baseline Score | 64 Mean Total POSAS Baseline Score | 65 Mean Total POSAS Baseline Score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 4 / 13 | 4 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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).
Time frame: up to 21 days
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silver Sulfadiazine | Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score | 29.9 score on a scale | Standard Deviation 10.5 |
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score | 30.5 score on a scale | Standard Deviation 12.5 |
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)
Time frame: up to 21 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Silver Sulfadiazine | Number of Days to Healing of the Superficial Partial Thickness Burn Wound. | 7 Days to healing |
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Number of Days to Healing of the Superficial Partial Thickness Burn Wound. | 9 Days to healing |
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.
Time frame: up to 21 days
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silver Sulfadiazine | 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. | 3.6 score on a scale | Standard Deviation 2.3 |
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | 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. | 3.2 score on a scale | Standard Deviation 1.6 |
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.
Time frame: up to 21 days
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silver Sulfadiazine | Safety- Infection Rate From Screening Visit to Visit 8 | 0 Participants |
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Safety- Infection Rate From Screening Visit to Visit 8 | 0 Participants |
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.
Time frame: up to 21 days
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silver Sulfadiazine | Safety- Rate of Complications From Screening Visit to Visit 8 | 1 Participants |
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Safety- Rate of Complications From Screening Visit to Visit 8 | 0 Participants |
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.
Time frame: up to 21 days
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silver Sulfadiazine | Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8 | 0 Participants |
| Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser | Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8 | 0 Participants |