Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections A… (NCT01297959) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery
United States503 participantsStarted 2013-01-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants In Intent to Treat (ITT) Analysis Set With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving Principal Incision Within 30 Days After Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively
Timeframe: Surgery (Day 0) up to 30 days post-surgery
2
Number of Participants In Per-Protocol (PP) Analysis Set With Superficial and Deep Incisional SSI Involving Principal Incision Within 30 Days After the Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively
Timeframe: Surgery (Day 0) up to 30 days post-surgery
✕. 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.