Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System

Study Overview
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Brief Summary
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Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to proved its safety and efficacy. In addition, this initial study will serve to yield blood bank and surgeon feedback towards improving the system.

Official Title
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Prospective, Randomized, Double Blinded, Parallel, Controlled, Two-arm, Two-center Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System

Conditions
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Reduction of Postoperative Adhesions

Intervention / Treatment
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* Procedure: Concentrate of plasma coagulation factors
* Procedure: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria PREOPERATIVE INCLUSION Preoperatively the patient must: Understand and be able to follow the requirements of the protocol including signing and dating an Ethics Committee approved Informed Consent prior to undergoing any protocol related procedures Patients undergoing any of the above procedures Male or female subjects > 18 years of age Subjects for whom a second abdominal surgery is planned within less than 12 months of the first surgical procedure BMI<40 INTRAOPERATIVE INCLUSION During surgery the patient must require having one of the following surgeries performed on their person: Planned or emergency colonic resection surgery with temporary stoma creation due to colonic perforation, acute diverticulitis or colonic obstruction. Surgery for low rectal cancer - low anterior resection. This surgery includes resection of lower part of rectum, colo-anal anastomosis and protective ileostomy creation. Usually patient undergo second stage procedure closure of ileostomy in 1-3 months. Total proctocolectomy and a pelvic pouch with diverting ileostomy in cases of surgery for Ulcerative colitis. In this kind of surgery there is the intention to close the temporary ileostomy in 1-3 months. Creation of stoma due to infectious process or trauma in the peritoneum (such as Fournier gangrene, laceration of rectum, etc.) Exclusion Criteria PREOPERATIVE EXCLUSION Preoperatively a patient must not: be unable to give their own written informed consent, be currently enrolled in another clinical study with drug or device related to adhesions or has participated in such a study within the last 30 days, have received or is expected to receive any other investigational product or technique belonging to the group of hemostats, adhesion reduction devices or other products, meshes, or other types of implants in the abdominal cavity within 30 days prior to or during enrolment, subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation for reasons other than rectal carcinoma. BMI≥40 Subjects who have received selective factor Xa inhibitors and/or direct thrombin inhibitors within 24 hours prior to surgery. Patients taking immune system suppressants deemed by the surgeon to interfere with wound healing, Patients taking daily doses of corticosteroids exceeding 20mg within the prior 30 days are to be excluded. Patients requiring perioperative corticosteroid supplementation are not to be excluded. Patients with a known history of severe multiple drug allergies Patients who have a life expectancy of less than 6 months because of a medical condition or disease state Any patient with a medical condition or other serious condition which will interfere with compliance and/or ability to complete this study protocol or who in the opinion of the investigator would not be a good candidate for enrollment INTRAOPERATIVE EXCLUSION Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure is not feasible for any reason Patients with peritoneal carcinomatosis Patients with endometriosis Use of hernia mesh in the first surgery. Subjects treated with hemostatic agents in which the sealant remains in the patient's body (e.g. Fibrin sealant).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double blinded, parallel, controlled, two-arm, two-center
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational arm<br>Treatment group receives a concentrate of coagulation factors. The device concentrates coagulation factors from donor plasma; the concentrate is applied to the surgical site intended to reduce the incidence, extent and severity of postoperative adhesions. | Procedure: Concentrate of plasma coagulation factors<br>* The plasma concentrate of coagulation factors is applied to the surgical site.<br>|
| Placebo Comparator: Control arm<br>Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma. | Procedure: 0.9% saline<br>* Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse event incidence | Incidence of adverse events related to treatment requiring any invasive procedure in the test group (who used blood plasma concentrate prepared using FuseX Anti-Adhesion System) compared to control group (who used normal saline processed by the same FuseX Anti-Adhesion System). | Within 30 days from the first surgery | 
| Overall adverse event incidence | Overall adverse event incidence will be evaluated by the presence and severity of adverse events and serious adverse events in the test group (who used blood plasma concentrate prepared using FuseX Anti-Adhesion System) vs. control group (who used normal saline processed by the same FuseX Anti-Adhesion System). | Until the second surgery but not longer than 7 months | 
| Severity of new formed adhesions in the target region | Severity of new formed adhesions having its source in the target region will be assessed by a blinded surgeon during the second surgery by grading the adhesion severity for each region on a scale from 0 (no adhesions) to 3 (strong vascularized adhesions that require sharp dissection and cannot be separated without tissue damage). The peritoneal cavity will be divided into 9 separate scoring regions. A peritoneal adhesion index (PAI) (sum of scores for all the regions) will be calculated per each patient. | Through study completion, an average of 1 year | 
| Usability as assessed by Surgeon questionnaire | a. Ease of application will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). b. Percentage of coverage the entire defined surgical field. c. mL of the materials used | Through study completion, an average of 1 year | 
| Usability as assessed by Operator questionnaire | a. Ease of device use will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). b. Device operation time | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of general surgical complications; incidence of minor adverse events | Incidence of general surgical complications including but not limited to: Septic shock, cardiovascular events, respiratory tract infections and pulmonary atelectasis, urinary tract infections, thromboembolic events Superficial Surgical Site Infections (SSI) - soft tissue infection, cellulitis, incisional abscess, wound dehiscence Deep SSI - abdominal abscess, pelvic abscess, peritonitis. Incidence of minor adverse events such as nausea, vomiting, abdominal pain, ileus, allergic reactions | Until the second surgery but not longer than 7 months | 
| Usability of the device Instructions for Use (questionnaire) | Usability of the device user manual will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy). | Through study completion, an average of 1 year |