Status:
TERMINATED
Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures
Lead Sponsor:
Next Science TM
Collaborating Sponsors:
Piedmont Healthcare
Hughston Clinic
Conditions:
Surgical Wound Infection
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures
Detailed Description
This is a prospective, controlled, double-arm, double-blinded, randomized clinical study of 30 subjects that are undergoing single stage surgical repair of Type II or IIIA or IIIB tibial fractures. I...
Eligibility Criteria
Inclusion
- Male or female 18 to 65 years old
- Scheduled to undergo surgery to repair open tibial fracture
- Willing and able to comply with all study procedures and be available for the duration of the study
- Provide signed and dated informed consent or obtain consent from legally authorized representative
- Not be pregnant, planning to become pregnant, or nursing female subjects.
Exclusion
- Unable to provide signed and dated informed consent or unable to obtain consent from a legally authorized representative
- Unable or unwilling to comply with all study-related procedures
- Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
- Subject has known history of contraindications to general anesthesia
- Subject with any underlying condition or state that, in the investigator's opinion, will make them too critically ill to complete 30 and/or 90 day follow ups
- Pregnant, planning to become pregnant, or nursing female subjects.
- Any subject positive for Covid-19 virus at time of surgical screening
- Tibial plateau, pilon, or Gustilo-Anderson type IIIc fractures and any fracture that will require referral to another surgical service will be excluded from this study
- Any patient who will require ongoing use of NPWT after hospital discharge will be excluded from the study.
- Subjects have evidence of prolonged QT segment, per EKG.
- Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04906642
Start Date
May 4 2021
End Date
September 1 2023
Last Update
November 3 2023
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Piedmont Healthcare
Columbus, Georgia, United States, 31901