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Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds

NCT06134843 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-06-11

No results posted yet for this study

Summary

The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery. Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic monitoring of their recovery.

Conditions

  • Skin Graft Complications

Interventions

COMBINATION_PRODUCT

DERMASEAL

plasma film containing metallic silver microparticles and fibrin

Sponsors & Collaborators

  • Vitruvian Medical Devices, Inc.

    collaborator INDUSTRY

  • Hobart W. Harris

    lead INDUSTRY

Principal Investigators

  • David M Young, MD · UCSF School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-01-31
Completion
2025-04-15
FDA Drug
Yes

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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 NCT06134843 on ClinicalTrials.gov