Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection … (NCT03574090) | Clinical Trial Compass
CompletedPhase 4
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
Spain268 participantsStarted 2020-10-20
Plain-language summary
The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery
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:
* Patients over 18 years of age.
* Patients who require urgent surgical intervention and who come from the emergency service
* Patients affected by complicated intra-abdominal infection with peritonitis of more than one abdominal compartment or intra-abdominal abscess requiring open surgical intervention.
Exclusion Criteria:
* Women patients with positive pregnancy test.
* Patients with primary peritonitis and liver cirrhosis.
* Patients who have received antibiotic treatment during the 72 hours prior to the surgical intervention (except that administered to UCIES as a treatment dose of the same process)
* Patients allergic to the antibiotic used in the study.
* Patients who have undergone a surgical procedure of recently opened abdomen (up to 30 days before surgery), a prosthesis of synthetic material (mesh) or to which the surgical wound can not be closed according to the surgeon's criteria.
* Patients with an unfavorable life prognosis (ASA 5).
What they're measuring
1
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI