Use of Topical Broad-spectrum Antibiotics as a Prophylaxis for Surgical Site Infection

OR20-00007

Ankle fractures are one of the most common injuries in traumatology. It is the fourth most common fracture in general population after hip, wrist, and hand fractures. These injuries are the second cause of hospitalization due to fractures. Surgical site infections can be divided according to the Center of Disease Control (CDC) in superficial surgical site infections whose are defined as any infection that happens within the next 30 days after the procedure, they involve only the skin and subcutaneous tissue of the incision, and the patient presents at least one of the following: purulent drainage of the superficial incision, microorganisms isolation from an aseptically obtained culture of body fluid or tissue or the pain existence, tenderness or local inflammation at the superficial incision site despite negative cultures. Also, a diagnosis made by the surgeon or attending medic.

2022-01-05

2023-12-21

2024-02-12

Completed

75

Inclusion Criteria: * • Patients older than 18 years * Patients with a closed fracture independently of mechanism and classification * Patients who require an open reduction with internal fixation surgery * Patients who decide to participate in the study Exclusion Criteria: * Patients with exposed fractures * Presence of any form of immune deficiency * Vancomycin hyper sensibility * Surgery in the affected ankle within the last six months * Steroid usage * Antibiotic usage one week prior entry

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of treatment with a surgical ankle fracture\n\n1. Surgical treatment\n2. Surgical treatment plus 1 g of topical vancomycin', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The patients involved in the protocol will be blinded', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}

2024-02-14