Surgical Site Infection Clinical Trial
Official title:
Prophylaxis of Surgical Wound Infection With Topical Antibiotics
Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.
Status | Recruiting |
Enrollment | 560 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients admitted for elective abdominal wall surgery by open route - Patients admitted for urgent or elective cesarean section - Patients undergoing elective surgery of the colon or rectum for neoplastic pathology (open or laparoscopy) - Patients undergoing emergency abdominal surgery (open or laparoscopy) Exclusion Criteria: - Patients under treatment with immunosuppressors, corticosteroids and patients on hemodialysis - Patients with primary peritonitis and liver cirrhosis - Patients with suspected allergy to the antibiotic used in the study - Patients who have recently undergone open abdomen surgery (up to 30 days pre-intervention) or to which the wound can not be closed surgical according to the surgeon's criteria - Patients with American Society of Anaesthesiology classification 5. |
Country | Name | City | State |
---|---|---|---|
Spain | Fundació Privada Hospital Asil de Granollers | Granollers | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital de Granollers |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical Site infection rate | signs of infection at any level of surgical site | 30 days | |
Secondary | Complications after surgery | Any complication after surgery, evaluated by the Clavien-dindo classification | 30 days |
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