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Superficial Partial-Thickness Burn Study

Primary Purpose

Superficial Partial Thickness Burn

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Silver Sulfadiazine

About this trial

This is an interventional treatment trial for Superficial Partial Thickness Burn

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UPMC Mercy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Silver sulfadiazine

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from screening visit to visit 8, in 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)

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 are then summed together to make up the total score (maximum of 60 and minimum of 6 for each section).

Secondary Outcome Measures

Safety- infection rate from screening visit to visit 8

Safety as measured by total incidences of infection from screening visit to visit 8

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

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

Safety- as measured by change in total Vancouver Scar Scale Score from screening visit to visit 8

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.

Full Information

NCT ID

NCT04601532

First Posted

October 19, 2020

Last Updated

October 6, 2022

Sponsor

J. Peter Rubin, MD

Collaborators

Synedgen, Inc., United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04601532

Brief Title

Superficial Partial-Thickness Burn Study

Official Title

Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-thickness Burns

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 11, 2021 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

J. Peter Rubin, MD

Collaborators

Synedgen, Inc., United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Superficial Partial Thickness Burn

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Masking

None (Open Label)

Allocation

Randomized

Enrollment

115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Silver sulfadiazine

Arm Type

Active Comparator

Arm Description

Arm Title

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Silver Sulfadiazine

Other Intervention Name(s)

Silvadene Topical Product

Intervention Description

Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.

Primary Outcome Measure Information:

Title

Change from screening visit to visit 8, in healing of the superficial partial thickness burn wound

Description

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

Title

Change from screening visit to visit 8 in total Patient and Observer Scar Assessment Scale (POSAS) score

Description

Time Frame

up to 21 days

Secondary Outcome Measure Information:

Title

Safety- infection rate from screening visit to visit 8

Description

Safety as measured by total incidences of infection from screening visit to visit 8

Time Frame

up to 21 days

Title

Safety- rate of noted wound progression from screening visit to visit 8

Description

Safety as measured by total incidence of progression of burn wounds to deep partial thickness/full thickness from screening visit to visit 8

Time Frame

up to 21 days

Title

Safety- rate of complications from screening visit to visit 8

Description

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

Time Frame

up to 21 days

Title

Safety- as measured by change in total Vancouver Scar Scale Score from screening visit to visit 8

Description

Time Frame

up to 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eleanor Shirley, MA, CCRC

Phone

412-641-8676

shirleye@upmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

Phone

412-648-9207

simopa@upmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Peter Rubin, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Mercy Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eleanor Shirley, MA, CCRC

Phone

412-641-8676

shirleye@upmc.edu

First Name & Middle Initial & Last Name & Degree

Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

Phone

412-641-8676

simopa@UPMC.EDU

First Name & Middle Initial & Last Name & Degree

Jenny Ziembicki, MD

First Name & Middle Initial & Last Name & Degree

Alain Corcos, MD

First Name & Middle Initial & Last Name & Degree

Garth Elias, MD

First Name & Middle Initial & Last Name & Degree

Rebecca Parsons, PA-C

First Name & Middle Initial & Last Name & Degree

Francesco Egro, MD

First Name & Middle Initial & Last Name & Degree

Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16614255

Citation

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Citation

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Citation

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Superficial Partial-Thickness Burn Study

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