NCT03574090

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Wound Infection
• Postoperative Wound Infection
• Postoperative Wound Infection Superficial Incisional
• Preventive Therapy

Interventions

Type	Name	Description
DRUG	Amoxicillin Clavulanate	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.
DRUG	Physiological Saline	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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2023-05-30
• Completion: 2023-06-11
• First posted: 2018-06-29
• Last updated: 2023-06-13

Locations

1 site across 1 country: Spain