A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RU… (NCT02280395) | Clinical Trial Compass
TerminatedPhase 1/2
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
Stopped: Company merger resulted in business decision to terminate the study.
United States9 participantsStarted 2014-10
Plain-language summary
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects undergoing abdominal surgery.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Willing and able to give written informed consent to participate in the study and authorization to release health information
* Males or females that are at least 2-years post-menopausal or surgically sterile; 18 to 75 years of age at screening
* Good general health defined as an ASA Physical Status score of moderate or 1 (healthy) or 2 (mild systemic illness), no clinically significant abnormal findings which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. Clinical laboratory values -\>/+20% outside the normal range may be deemed acceptable
* Willing and able to follow study instructions and available to complete all study requirements and visits
* Scheduled to undergo a planned, non-emergent abdominal surgical procedure involving an open incision of ≥7 cm and ≤35 cm in length. Eligible surgeries include, but may not be limited to: left hemicolectomy, right hemicolectomy, transverse colectomy, total abdominal colectomy with ileorectal anastomosis, lower anterior surgeries, abdominoperineal resection, Ileostomy closures and HARTMAN take down.
Exclusion Criteria:
* Tumor debulking, contaminated surgeries (e.g., extruded bowel) minimally invasive procedures, Caesarian section and hysterectomy
* Laparoscopic appendectomy
* History of allergy or sensitivity to any components of the investigational product
* Body mass index \[BMI\] \>40
* American Society of Anesthesiologists' (AS…
What they're measuring
1
Safety and tolerability will be determined by nature and incidence of adverse events and clinical laboratory values compared to saline control group. Wound site physical inspection tabulated result compared to saline control group.