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

Phase 4

Completed

• Conditions: Preventive Therapy; Surgical Wound Infection; Postoperative Wound Infection; Postoperative Wound Infection Superficial Incisional
• Interventions: Drug: Amoxicillin Clavulanate; Drug: Physiological Saline

• Registration Number: NCT03574090
• Lead Sponsor: Universitat Internacional de Catalunya

Brief 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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-29
• Study Start: 2020-10-20
• Primary Completion: 2023-05-30
• Status Verified: 2023-06
• Study Completion: 2023-06-11
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amoxicillin clavulanate	Amoxicillin Clavulanate	1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
amoxicillin clavulanate	Physiological Saline	1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
Physiological Saline	Physiological Saline	500 milliliters of 0.9% Physiological Serum.

Primary Outcome Measures

Name	Time	Method
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI	30 days	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

Secondary Outcome Measures

Name	Time	Method
Bacterial charge	30 days	Effect of topical prophylaxis protocol on reducing bacterial charge
reduction of hospital stay	30 days	Effect of the protocol of topical prophylaxis in the reduction of hospital stay
Bacterial resistance	30 days	Effect of topical prophylaxis protocol on Bacterial resistance

Trial Locations

Locations (1)

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain