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



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:June 2016

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Phase 3 Study of the Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections Among Colorectal Surgery Patients (Triple IN Study-INhibition of INcisional INfections)

This study is intended to determine the efficacy 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.

The purpose of this standard-of-care, pivotal Phase 3 study is to evaluate the efficacy and
safety of topical E-101 Solution after direct application into the principal surgical
incision in the prevention of superficial and deep incisional surgical site infections (SSI)
within 30 days after elective colorectal surgery. The study is intended to support a target
indication statement of: "E-101 Solution is indicated for the prophylaxis of incisional
surgical site infections following elective colorectal surgery". E-101 Solution is comprised
of the active ingredients of glucose oxidase (GO) and porcine myeloperoxidase (pMPO) that
produce coupled reactions after the addition of glucose substrate. The hypothesis is that
E-101 Solution topically applied directly into the principal incision is safe and
significantly reduces the incidence of incisional SSI compared to placebo topical
application. (The principal surgical incision is ≥ 5cm and < 35 cm used as a hand port,
colorectal specimen extraction port, or extracorporeal manipulation port depending on the
specific colorectal surgical approach.)

Inclusion Criteria:

1. 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.

2. Able to give informed consent.

3. Male or female ≥18 years of age.

4. If female, is non-pregnant (negative pregnancy test result at the
Screening/Randomization Visit) and non-lactating.

5. 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.

Exclusion Criteria:

1. Hypersensitivity to porcine products.

2. History of known anti-myeloperoxidase autoantibodies (i.e., pANCA), as well as
patients 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]).

3. 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.

4. Absolute contraindication to general anesthesia.

5. Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or
sutures. (Note: If there can be assurances that the subject will not be exposed to
these materials that cause hypersensitivity, alternatives will be allowed.)

6. History of keloid or hypertrophic scarring within or near an incision from a prior
surgery.

7. Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor
wound healing).

8. ASA score > 3.

9. 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.

10. 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.

11. 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.

12. Preoperative severe neutropenia (total neutrophil count ≤500 X 109/L). (Note: Testing
should be performed at the local laboratory.)

13. 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.)

14. 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.

15. 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.

16. History of a complicated laparotomy within 30 days prior to planned index-surgery.

17. 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.

18. 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.)

19. 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).

20. Patients 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).

21. Preoperative prothrombin time or INR > 2 x upper limit of normal. (Note: Testing
should be performed at the local laboratory.)

22. Postsurgical life expectancy ≤ 60 days (in the Investigator's or Sponsor's opinion).

23. Any patient 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.

24. Patients with severe COPD that are likely to need > 24 hours postoperative ventilator
support (e.g., patients 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).

25. If, in the opinion of Investigator, the potential subject would likely be unable to
maintain adequate care of the principal incision post-operatively.

26. Anticipate that patient will not be available for study visits/ procedures or if in
the opinion of Investigator there is concern that patient might not comply with study
visits/procedures (e.g., due to ongoing illicit drug usage or alcohol abuse).

27. Lack of willingness to have personal study-related data collected, archived, or
transmitted under a blinded condition to regulatory agencies.

28. Participation within 30 days before the start of this study in any experimental drug
or device study; or currently participating in a study in which the administration of
investigational drug or device within 60 days is anticipated.
We found this trial at
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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3550 Jerome Avenue
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(718) 920-4321
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Los Angeles, California 90033
213) 740-2311
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
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Albany, New York 12208
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Brandon, Mississippi 39042
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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Chicago, Illinois
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
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Detriot, Michigan 48202
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Freehold, New Jersey 07728
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Haifa, 31096
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Houston, Texas 77030
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Metairie, Louisiana 70006
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
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New York, New York 10029
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Omaha, Nebraska 68114
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Pittsfield, Massachusetts 01201
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Portland, Oregon 97227
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San Antonio, Texas 78229
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1959 NE Pacific St
Seattle, Washington 98195
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St. Louis, Missouri 63108
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300 Pasteur Dr
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101 Nicolls Rd
Stony Brook, New York 11794
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Sugarland, Texas 77479
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