A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60 Lavage Following Abdominal Surgery as an Adjunctive Therapy to Prophylactic Systemic Antibiotics
Overview
- Phase
- Phase 1
- Intervention
- RUT058-60
- Conditions
- Postoperative Wound Infection-deep
- Sponsor
- Pulmatrix Inc.
- Enrollment
- 9
- Locations
- 4
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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 (Group B) in adult subjects undergoing abdominal surgery.
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 use of prophylactic systemic antibiotics and improvements in surgical techniques, surgical site infections continue to be associated with significant morbidity, reduction in quality of life and overall cost following abdominal surgery. Ruthigen is conducting this Phase I/II clinical study to evaluate the safety and potential efficacy of RUT058-60 in preventing surgical deep incisional and organ space infection in subjects undergoing abdominal surgery as an adjunctive therapy to prophylactic systemic antibiotics.
Investigators
Eligibility Criteria
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' (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
- •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
Arms & Interventions
RUT058-60
Intervention: RUT058-60
Sterile Saline for Irrigation
Intervention: Sterile saline for irrigation
Outcomes
Primary Outcomes
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.
Time Frame: 28 Days
Secondary Outcomes
- Potential efficacy will be determined by the proportion of subjects who do not develop a surgical deep incisional or organ/space infection by Day 28 post-application compared to the saline control group.(28 Days)