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Superficial Partial-Thickness Burn Study

NCT04601532 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-01

Study results available
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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

Interventions

DEVICE

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.

DRUG

Silver Sulfadiazine

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

Sponsors & Collaborators

  • Synedgen, Inc.

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • J. Peter Rubin, MD

    lead OTHER

Principal Investigators

  • J. Peter Rubin, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2022-12-08
Completion
2022-12-08
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04601532 on ClinicalTrials.gov