A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60

Stopped early · Phase 1/Phase 2

Conditions studied: Postoperative Wound Infection-deep, Post Operative Wound Infection

In brief

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.

Key facts

Study ID

NCT02280395

Run by

Pulmatrix Inc.

People needed

9

Starts

2014-10-01

Expected to finish

2015-06-01

Last updated by the study team

2021-01-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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' (ASA) Classification of Physical Status score ≥ 3 (severe systemic illness)
• Evidence preoperatively, of any of the following: sepsis, severe sepsis, or septic shock, or a history of delayed wound healing
• Current surgical site infection (superficial, deep incisional or organ/space) secondary to previous laparotomy/ laparoscopy, or from any other cause
• Receiving any oral or intravenous antibiotics within 1-week prior to Baseline Day 0. Prophylactic antibiotics for dental or other brief procedures are acceptable. Pre-surgical administration of antibiotics is required as part of surgery preparation.
• Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin
• History of chemotherapy within 4-weeks or radiation therapy within 4-weeks prior to Baseline
• Terminal illness with life expectancy of less than 6 months from Baseline
• Current smokers, malnourished subjects, subjects with diabetes or uncontrolled serum glucose
• History of major organ transplantation, including bone marrow transplantation
• History of laparotomy within 60-days prior to Baseline
• Preoperative pain threshold (PT) or international normalized ration (INR) >2 x upper limit of normal
• Taking the following concomitant medications within 2 weeks prior to Baseline; systemic steroids or other anti-inflammatory/immunosuppressive medication, or have a history of a current immunosuppressive condition or immune deficiency.Anti-inflammatory medications taken pro re nata (PRN) are allowed per institution/ investigator restriction
• HIV patients or patients with Hepatitis B or C
• Prosthetic cardiac valve or joint prostheses and any potential for remote body site infection
• Medically significant cardiac arrhythmia, or prolonged corrected QT interval (QTc) interval >450 msec
• An ATE (MI, cerebrovascular attack [CVA], TIA), venous thromboembolic event [VTE] (e.g., deep vein thrombosis [DVT], PE), within 12 months of Baseline
• Increased hemorrhage risk (e.g., coagulation disorders)
• Women of child bearing potential (WOCBP) or females that are pregnant, nursing, or planning a pregnancy during the study
• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
• Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All subjects must be afebrile at Baseline (i.e., <38.0° Celsius [C])
• History of stage IV cancer*, other clinically significant renal, hepatic, neurologic, hematologic, respiratory, psychiatric, cardiovascular, infectious disease, psychological condition or social situation which, in the opinion of the Investigator, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• University of California, San Diego, Thornton Hospital — La Jolla, California, United States
• BJJS, Corp., Memorial Hermann Memorial Medical Center — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.