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

Universitat Internacional de Catalunya

Status and phase: Completed; Phase 4

Conditions: Postoperative Wound Infection Superficial Incisional; Preventive Therapy; Surgical Wound Infection; Postoperative Wound Infection

Treatments: Drug: Amoxicillin Clavulanate; Drug: Physiological Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03574090

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Details and patient eligibility

About

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

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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268 participants in 2 patient groups

amoxicillin clavulanate

Experimental group

Description:

1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.

Treatment:

Drug: Physiological Saline

Drug: Amoxicillin Clavulanate

Physiological Saline

Active Comparator group

Description:

500 milliliters of 0.9% Physiological Serum.

Treatment:

Drug: Physiological Saline