Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Infections

In brief

This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being developed for direct application to a surgical incision.

Key facts

Study ID

NCT01297959

Run by

Excited States, LLC

People needed

503

Starts

2013-01-10

Expected to finish

2015-10-14

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo elective colon and/or rectal surgical procedures involving open laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The principal incision must have a length of > 5 cm and < 35 cm in length. Eligible surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy, ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis, and abdominal perineal resection of the rectum.
• Able to give informed consent.
• If female, is non-pregnant (negative pregnancy test result at the Screening/Randomization Visit) and non-lactating.
• If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth control and agrees to continue with this regimen over the study surveillance period:
• Oral, implantable, or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit
• Intrauterine device
• Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream)
• Not sexually-active. Agreement to be available for evaluation at the study site for scheduled visits.

You may not qualify if…

• Hypersensitivity to porcine products.
• History of known anti-myeloperoxidase autoantibodies (i.e., perinuclear anti-neutrophil cytoplasmic antibody [pANCA]), as well as participants with known idiopathic necrotizing glomerulonephritis and certain systemic vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels, Wegener's granulomatosis, and Churg-Strauss Syndrome]).
• Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any antimicrobial-embedded suture to close the principal incision or any suture in the surgical field that has not been formally approved by the relevant local national regulatory authority.
• Absolute contraindication to general anesthesia.
• Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or sutures. (Note: If there can be assurances that the participant will not be exposed to these materials that cause hypersensitivity, alternatives will be allowed.)
• History of keloid or hypertrophic scarring within or near an incision from a prior surgery.
• Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor wound healing).
• American Society of Anesthesiologists (ASA) Score > 3.
• Undergoing emergency colorectal surgery such that standard bowel preparation and other standard preoperative precautions and assessments cannot be performed in time before the index-surgery.
• The planned index-surgery involves removal or placement of mesh (either synthetic or biological) as part of closure in the principal incision or traversing any part of a pre-existing mesh (either synthetic or biological) in the principal incision.
• There are clinical signs of overt infection necessitating systemic antibiotics via oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall, peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.
• Preoperative severe neutropenia (total neutrophil count ≤500 X 109/L). (Note: Testing should be performed at the local laboratory.)
• Receiving any oral or intravenous antibiotics within 24 hours prior to the index-surgery. (Note: It is permissible to administer conventional oral prophylactic antibiotics as bowel preparation up to the time of the index- surgical procedure, as well as intravenous or intramuscular prophylactic antibiotics just prior to the index-surgery as per the treating surgeon's standard of care.)
• Preoperative evaluation that the intra-abdominal process might preclude full closure of the skin incision due to severe or morbid obesity (i.e., any mechanical reason that would prevent/preclude primary intent wound healing) at the principal incision.
• History of major organ transplantation (e.g., lung, liver, or kidney), including bone marrow transplantation, or intent to perform major organ transplant as a concomitant surgery.
• History of a complicated laparotomy within 30 days prior to planned index-surgery.
• Planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery.
• Likely preoperative urinary tract infection, as evident by: i) symptoms of upper urinary tract infection (e.g., fever and/or flank pain) or ii) symptoms of lower urinary tract infection (e.g., urinary frequency, dysuria, urgency, and/or suprapubic pain); accompanied by any one of the following: 1) bacteriuria of ≥104 bacteria/mL urine or 2) positive urine leucocyte esterase or positive nitrite urine dipstick tests. Also exclude any man under age 60 years who has both positive urine nitrite and leucocyte esterase dipstick tests - even if he is asymptomatic (unless he has predisposing factors for urinary tract infection - e.g., spinal cord injury). (Note: Testing should be performed at the local laboratory.)
• Undergoing a significant concomitant surgical procedure (e.g., hysterectomy) or any mesh repair (either synthetic or biological mesh) as part of closure. The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, removal of Meckel's diverticulum, primary repair of small ventral hernia (i.e., <30 cm2), liver biopsy/wedge resection (but not liver resection).
• Participants with a condition (e.g., recurrent urinary tract infections, nail infections, sinusitis, dental infections, vaginitis/vaginosis, or chronic bronchitis) requiring frequent or chronic administration of antimicrobials (received antibiotics/antimicrobials at least twice for ≥ 2 weeks during past 6 months).
• Preoperative prothrombin time or international normalized ratio (INR) > 2 x upper limit of normal. (Note: Testing should be performed at the local laboratory.)
• Postsurgical life expectancy ≤ 60 days (in the Investigator's or Sponsor's opinion).
• Any participant in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iii) placement of a drain into the intraperitoneal space that emerges through the principal incision; and iv) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs.
• Participant with severe Chronic obstructive pulmonary disease (COPD) that are likely to need > 24 hours postoperative ventilator support (e.g. participant on chronic or intermittent supplemental oxygen or an estimated forced expiratory volume in 1 second (FEV1) less than 50% of expected based on bedside spirometry).
• If, in the opinion of Investigator, the potential participant would likely be unable to maintain adequate care of the principal incision post-operatively.

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Sheridan Clinical Research, Inc. — Sunrise, Florida, United States
• University of South Florida/Tampa General Hospital — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Stoger Hospital of Cook County — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Colon & Rectal Surgery Associates — Metairie, Louisiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation / Colon and Rectal Surgery — New Orleans, Louisiana, United States
• Berkshire Medical Center, Inc — Pittsfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Medical IQ — Brandon, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Colon and Rectal Surgery, Inc. — Omaha, Nebraska, United States
• CentraState Medical Center — Freehold, New Jersey, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Meridian Health Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Montefiore Medical Center — The Bronx, New York, 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.