Surgical Wound Infection
Conditions
Keywords
Postoperative Wound Infection, Surgical Wound Infection, Colorectal Surgery Infection Prophylaxis
Brief summary
Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery. \+ Control group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc. There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field
Interventions
DRUGExtra dosage - cefuroxime (750mg) I.V
In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc
PROCEDUREColorectal Surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
DRUGCiprofloxacin 750 mg oral
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
DRUGMetronidazole 250 mg oral
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
DRUGCefuroxime 1.5 g Intravenous
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting colonic pathology * The surgery is not contraindicated * Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..) * Indication of segmentary resection or total colectomy * Patients who agree to participate voluntarily in the study and signed an informed consent.
Exclusion criteria
* Patients who refuse to participate in the study. * Patients undergoing mechanical colon preparation the day before surgery. * Patients with rectal cancer * Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis). * Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery. * Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis) * Patients presenting allergy to the drugs under study. * Patients that will not strictly follow the assigned prophylaxis regimen * Patients undergoing urgent surgery (\<24h)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound infection | 30 days | Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local infection | 30 days after surgery | Superficial, deep, body-cavity * This is a Clinical measure supported by image if necessary * This morbidity problems are reported independently as a YES/NO variable |
| Hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 7 days | Hospital stay since colorectal surgery is done |
| Direct Adverse Drug Reactions | 24 hours since the drug is taken | Allergic reactions Intolerance •This morbidity problems are reported independently as a YES/NO variable |
| Occlusive problems | 30 days from surgery | Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(\>5days),.... Occlusive problems, Iatrogenic problems, Impaired healing ( Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...) Bleeding problems, Cardiac complications, Nephro-urinary complications, Respiratory complications, Vascular Complications, Gastrointestinal complications, Neurological complications, Local complications... •This morbidity problems are reported independently as a YES/NO variable |
| Iatrogenic problems | 30 days after surgery | Damage to structures such as ureters, bowel loops artery / iliac vein .... •This morbidity problems are reported independently as a YES/NO variable |
| Impaired healing | 30 days after surgery | * This is a Clinical measure always supported by image tests. * This morbidity problems are reported independently as a YES/NO variable |
| Neurological complications | 30 days after surgery | Disorientation, cerebral vascular accident, ... * This is a Clinical measure. * This morbidity problems are reported independently as a YES/NO variable. * Neurologist report will be required beyond disorientation. |
| Cardiac complications | 30 days after surgery | acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema * This is a Clinical measure supported by more specific tests if necessary. * This morbidity problems are reported independently as a YES/NO variable * Cardiologist report will be required for including this items |
| Nephro-urinary complications | 30 days after surgery | Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ... * This is a Clinical measure supported by more specific tests if necessary. * This morbidity problems are reported independently as a YES/NO variable |
| Respiratory complications | 30 days after surgery | Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ... * This is a Clinical measure always supported by image . * This morbidity problems are reported independently as a YES/NO variable |
| Vascular Complications | 30 days after surgery | Deep venous thrombosis, phlebitis, thrombophlebitis, ... * This is a Clinical measure supported by more specific test if necessary . * This morbidity problems are reported independently as a YES/NO variable |
| Gastrointestinal complications | 30 days after surgery | Liver failure, gastrointestinal bleeding, severe malnutrition, ... * This is a Clinical measure supported by blood test and further test if necessary * This morbidity problems are reported independently as a YES/NO variable |
| Local complications | 30 days after surgery | Hematoma, seroma, evisceration * This is a Clinical measure. * This morbidity problems are reported independently as a YES/NO variable |
| Bleeding problems | 30 days after surgery | Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... •This morbidity problems are reported independently as a YES/NO variable |
Countries
Spain
Outcome results
None listed