Clinical trial NCT03574090: Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
Official title: PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Wound Infection
Postoperative Wound Infection
Postoperative Wound Infection Superficial Incisional
Preventive Therapy
Keywords: topical antibiotic
surgical wound infection
prevention of surgical wound infection
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Hospital de Granollers
First posted: 2018-06-29
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI
timeFrame: 30 days
Secondary outcomes:
measure: reduction of hospital stay
timeFrame: 30 days
measure: Bacterial charge
timeFrame: 30 days
measure: Bacterial resistance
timeFrame: 30 days
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Josep Maria Badia Perez, PH. D
role: STUDY_DIRECTOR
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