Hospital General de Granollers
Granollers, Barcelona, 08402, Spain
NCT Number: NCT03574090
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
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Granollers, Barcelona, 08402, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 1000 mg amoxicillin and 200mg clavulanic acid.
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.
Other names: 500 milliliters of 0.9% Physiological Serum
Time frame: 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
Time frame: 30 days
Effect of the protocol of topical prophylaxis in the reduction of hospital stay
Time frame: 30 days
Effect of topical prophylaxis protocol on reducing bacterial charge
Time frame: 30 days
Effect of topical prophylaxis protocol on Bacterial resistance
Universitat Internacional de Catalunya
Other
PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery
Acronym: PROTOP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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