Status:
TERMINATED
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
Lead Sponsor:
Pulmatrix Inc.
Conditions:
Postoperative Wound Infection-deep
Post Operative Wound Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 (Grou...
Detailed Description
Post-surgical site infections account for approximately 20% of total healthcare-associated infections (HAI), making surgical site infections the most common HAI in US hospitals. Despite the routine us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02280395
Start Date
October 1 2014
End Date
June 1 2015
Last Update
January 12 2021
Active Locations (4)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States, 36695
2
University of California, San Diego, Thornton Hospital
La Jolla, California, United States, 92037
3
BJJS, Corp., Memorial Hermann Memorial Medical Center
Houston, Texas, United States, 77024
4
University of Virginia
Charlottesville, Virginia, United States, 22904