RECRUITING

NO Sensor to Record Wound Data in Acute or Chronic Wounds

Description

The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.

Study Overview

Study Details

Study overview

The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.

A Single-Center Pilot Study to Test the Effectiveness of the REPAIR Nitric Oxide (NO) Sensor to Record Wound Characteristic Data

NO Sensor to Record Wound Data in Acute or Chronic Wounds

Condition
Volumetric Muscle Loss
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Mercy, Pittsburgh, Pennsylvania, United States, 15219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Extremity injury
  • 2. Wound surface area 2-10 cm in diameter
  • 3. Wound amenable to NO Sensor placement
  • 4. Age at the time of consent ≥ 22 to ≤ 65 years
  • 5. Cognitively able to undergo informed consent discussion and understand the study
  • 1. Chemotherapy
  • 2. Pregnancy
  • 3. Preexisting immunosuppressive conditions or immunosuppression therapy
  • 4. Active hemorrhage in the wound bed
  • 5. Physician discretion for patients with complex medical conditions or high mortality risks
  • 6. Patients with an active implanted device, such as a pacemaker, defibrillator, or hypoglossal or vagal nerve stimulator
  • 7. Patients requiring a legally authorized representative (LAR) for informed consent

Ages Eligible for Study

22 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stephen Badylak,

Stephen Badylak, MD,DVM,PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2025-06-30