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

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.

Institutional Review Board (IRB) approval is required before the site can begin enrolling patients. Additionally, protocol amendments need to be approved by the IRB prior to starting any changes or procedures stemming from the amended protocol. Potentially eligible patients will be offered study enrollment and all subjects are required to participate in the informed consent process and sign the most recent IRB-approved written informed consent document prior to being enrolled in the study. If all the study inclusion/exclusion criteria are met, patients will be presented with the option to participate in the study and informed consent procedures will be carried out, in compliance with currently applicable subjects' rights and safety regulations. Reconsenting procedures for cases of protocol amendments will be performed in compliance with the IRB.

Patients who present for open tibial fracture repair surgery will have a pre-op medical evaluation prior to being screened against the protocol's inclusion/exclusion criteria. If criteria are met, patients will be presented with the option to participate in the study, and informed consent procedures will be carried out, in compliance with currently applicable participants' rights and safety regulations. At the time of surgery, participants determined to require surgical repair of a Type IIIC tibial fracture will be excluded. Patients who continue to be eligible meeting inclusion/exclusion criteria at the time of surgery will be randomized to one of the two treatment arms: SOC with Saline or SOC plus Next Science treatment. The treatment assignment will be predetermined by a randomization plan within Castor Electronic Data Capture (EDC) system. Although, paper source documents will be used to obtain subject data, randomization will be primarily through the EDC system. As a back-up, should the EDC system be unavailable at that time, randomization will occur using a sealed envelope system.

The following must have occurred prior to determining treatment assignment:

• Screening
• Participant must meet all eligibility requirements
• Informed Consent must be signed
• Continued Eligibility screening

• Randomization must occur*

  • Randomization occurs prior to surgery based on Exclusion #8. If the index fractures are bilateral, right leg will be randomized while the other leg will be assigned to the opposite treatment arm to prevent dosing of identical products on one subject.

Once surgical evaluation occurs if the index fracture is determined to be Type II, IIIA or IIIB (that does not require referral to another surgical service [vascular, plastic surgery] ) then the subject will continue to dosing. If the index fracture(s) must receive additional surgical referrals they will not be dosed, considered a screen failure, and exited from the study.

If the patient fails to meet continued eligibility:

• Screen Failure and
• Study Exit forms must be completed.

Accurate recording of the information per section 9.3 is critical for the traceability of treatment and product to a participant.

The duration of each subjects' participation once eligible and approved to start treatment, will start from Day 1 (first index surgery) and end at the Day 90 Visit. On-site visits will be carried out at Screening/Enrollment; Day of Surgery; Day of Discharge; and Days 14, 30, and 90; consisting of safety, bone healing (via X-ray findings), bioburden assessment, and surgical site infection assessment questions.

The key parameters of the study include bioburden and surgical site infection assessment, re-admission assessment, serious adverse events, and healthcare cost impact.

Bacterial identification and quantification will be evaluated via two methods: PCR/NGS (according to this protocol) and microbiology/pathology (according to site SOC). PCR/NGS swabs will be taken after fracture fixation inside the wound and then around the closed surgical incision:

• After fracture fixation (deep tissue): Swabs will be performed right after fracture fixation, before blinded rinse, and then immediately after blinded irrigation. The swabs will be performed on the entire wound base and around the fixation device. The time of collection for each swab must be specific (hour and minute) and recorded on the specimen label and requisition form.
• After closed surgical incision (superficial): After final closure, swabs will be taken within the 1-2cm perimeter surrounding the entire incision. This will be repeated on the day of discharge. The time of collection for each swab must be specific (hour and minute) and recorded on the specimen label and requisition form.