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

NCT02280395 | Terminated Phase 1 DMC

• 1 other identifier: CP02-117838
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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.

Conditions

Postoperative Wound Infection-deep; Post Operative Wound Infection

Outcome Measures

Primary Outcomes (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.

  28 Days

Secondary Outcomes (1)

• 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

Other Outcomes (3)

• Exploratory Analysis- Overall length of hospital stay

  28 Days

• Exploratory Analysis- Readmission to the hospital within the first 28-days post-operative procedure

  28 Days

• Exploratory Analysis- Incisional wound healing time frame

  28 Days

Study Arms (2)

RUT058-60

EXPERIMENTAL

Drug: RUT058-60

Sterile Saline for Irrigation

PLACEBO COMPARATOR

Drug: Sterile saline for irrigation

Interventions

RUT058-60 DRUG

Prior to closure of the abdomen at the end of the surgical repair, each subject will undergo lavage with approximately 900 mL of RUT058-60 administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

RUT058-60

Sterile saline for irrigation DRUG

Prior to closure of the abdomen, each subject will undergo lavage with approximately 900 mL of sterile saline administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

Sterile Saline for Irrigation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pulmatrix Inc.: lead

Study Sites (4)

University of South Alabama Medical Center

Mobile, Alabama, 36695, United States

Location

University of California, San Diego, Thornton Hospital

La Jolla, California, 92037, United States

Location

BJJS, Corp., Memorial Hermann Memorial Medical Center

Houston, Texas, 77024, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Traci Hedrick, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Timothy I Melson, MD

  Shoals Medical Trials, Helen Kellar Hospital

  PRINCIPAL INVESTIGATOR

• Harold Minkowitz, MD

  BJJS Corporation, Memorial Hermann Memorial Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Rider, MD

  University of South Alabama Medical Center

  PRINCIPAL INVESTIGATOR

• Sonia Ramamoorthy, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• AnaMaria Garza, MD

  PVMDI, Glendale Memorial (Dignity Health)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (4)