Superficial Partial-Thickness Burn Study

NCT04601532 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: STUDY20050205
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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)

Conditions

Superficial Partial Thickness Burn

Outcome Measures

Primary Outcomes (2)

• 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in POSAS score between the baseline and last assessment completed (21 days if last visit completed, or earlier visit if withdrawn or lost to follow up).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

Secondary Outcomes (4)

• Safety- Infection Rate From Screening Visit to Visit 8

  up to 21 days

• Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8

  up to 21 days

• Safety- Rate of Complications From Screening Visit to Visit 8

  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.

  up to 21 days

Study Arms (2)

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.

Drug: Silver Sulfadiazine

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.

Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Interventions

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.

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Silver Sulfadiazine DRUG

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

Also known as: Silvadene Topical Product

Silver sulfadiazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• J. Peter Rubin, MD: lead
• Synedgen, Inc.: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (18)

• 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.

  PMID: 16614255 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.

  PMID: 26724539 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.

  PMID: 22030441 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.

  PMID: 29901799 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.

  PMID: 23740764 BACKGROUND

• Wasiak J, Cleland H. Burns: dressings. BMJ Clin Evid. 2015 Jul 14;2015:1903.

  PMID: 26173045 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.

  PMID: 29342216 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.

  PMID: 30123191 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.

  PMID: 2373734 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.

  PMID: 15720096 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.

  PMID: 14636751 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.

  PMID: 8537427 BACKGROUND

• Maruish M. User's manual for the SF-12v2 Health Survey. 3. Lincoln, RI: QualityMetric Inc.; 2012.

  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.

  PMID: 19424821 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.

  PMID: 15253184 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.

  PMID: 16079683 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.

  PMID: 29180591 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.

  PMID: 28742235 BACKGROUND

MeSH Terms

Interventions

Silver Sulfadiazine

Intervention Hierarchy (Ancestors)

Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Eleanor Shirley, MA CCRC
• Organization: University of Pittsburgh

shirleye@upmc.edu

412-383-7712

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Endowed Chair of Plastic Surgery

Model Details: 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).

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: June 11, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)