Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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Is a clinical trial phase IV prospective, blind, controlled and random allocation of treatment with the active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%. To demonstrate its effectiveness in the surgical wound infection prophylaxis be used in contaminated surgery and be compared its effectiveness with the topical administration of normal saline only.

Official Title
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PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery

Conditions
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Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional, Preventive Therapy

Intervention / Treatment
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* Drug: Amoxicillin Clavulanate
* Drug: Physiological Saline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amoxicillin clavulanate<br>1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum. | Drug: Amoxicillin Clavulanate<br>* To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.<br>* Other names: 1000 mg amoxicillin and 200mg clavulanic acid.;Drug: Physiological Saline<br>* To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.<br>* Other names: 500 milliliters of 0.9% Physiological Serum;|
| Active Comparator: Physiological Saline<br>500 milliliters of 0.9% Physiological Serum. | Drug: Physiological Saline<br>* To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.<br>* Other names: 500 milliliters of 0.9% Physiological Serum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI | Evaluation of the effect of topical antibiòtic ( Amoxicillin 1000mg and 200mg of Clavulanic acid dissolved in 500 milliliters of 0.9% Physiological Serum ) prophylaxis on the incidence of Surgical Site Infection in surgery due to emergency intra-abdominal infection | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of hospital stay | Effect of the protocol of topical prophylaxis in the reduction of hospital stay | 30 days | 
| Bacterial charge | Effect of topical prophylaxis protocol on reducing bacterial charge | 30 days | 
| Bacterial resistance | Effect of topical prophylaxis protocol on Bacterial resistance | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical antibiotic, surgical wound infection, prevention of surgical wound infection