Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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 incisional hernia repair after abdominal surgery.

Method. Randomized double-blind clinical trial comparing two groups of topical prophylaxis. Follow-up will be 90 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Granollers
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acid; Clavulanic Acids; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients who require an elective surgical procedure due to an abdominal wall incisional hernia.

Exclusion Criteria:

• Emergency surgery

• Parastomal hernia

• Patients under treatment with immunosuppressants, corticosteroids and patients on hemodialysis.

• Patients with liver cirrhosis.

• Patients with suspected allergy to bata-lactams antibiotics.

• Patients who have undergone a recent open abdomen surgical technique (up to 30 days pre-intervention), placement of a prosthesis made of synthetic material (mesh) or in which the wound cannot be closed surgery at the discretion of the surgeon.

• Patients defined as ASA (American Association of Anaesthesiologists) 5, according to the American Association of Anaesthesiologists classification.