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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30
The plasma concentrate of coagulation factors is applied to the surgical site.
Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.
Kaunas Clinical Hospital
Kaunas, Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania
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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
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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
Time frame: 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).
Time frame: Through study completion, an average of 1 year