Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures

NCT04906642 | Terminated FDA Device

• 1 other identifier: CSP-018
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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

Conditions

Surgical Wound Infection

Keywords

Open tibial fracture; Surgical Site Infection; Surgical Irrigation; Single Stage Closure

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  Proportion of subjects that develop a surgical site infection (superficial, deep, or organ space) from surgery to post-op Day 90 for the Next Science Group compared to the Control group.

  90 days

Secondary Outcomes (2)

• Superficial Bioburden

  90 days

• Deep Bioburden

  1 day

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Each of the following procedures will be conducted according to general or local site Standard of Care (SoC): * Medication administration at surgery * Surgical irrigation and wound debridement * Surgical fracture preparation/fixation * Surgical closure

Other: Standard of Care

Standard of Care plus Next Science

EXPERIMENTAL

In addition to the SoC, the blinded product will be applied in place of saline irrigation as the wound is closed (after bone fracture preparation/fixation), depending on the randomization.

Device: Next Science

Interventions

Next Science DEVICE

Solution is a clear, colorless, aqueous solution that is used to remove debris, including microorganisms, from wounds via hydrodynamic shear across the wound. This aids in the removal of foreign material such as, microorganisms, dirt, and debris.

Standard of Care plus Next Science

Standard of Care OTHER

Normal Saline will be used in place of Next Science for irrigation

Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Next Science TM: lead
• Piedmont Healthcare: collaborator
• Hughston Clinic: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Piedmont Healthcare

Columbus, Georgia, 31901, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert Harris, MD

  Piedmont Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the double-blinded nature of the study, neither the participant, treating physician, site staff, or site study team will be aware of the treatment assignment (XPERIENCE No-Rinse Antimicrobial Solution or blinded saline) of each subject.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, double-blinded clinical study

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Study Start: May 4, 2021
• Primary Completion: July 5, 2023
• Study Completion: September 1, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)