CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
PrevOmega +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04341805
NCT04341805N/ACompleted
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Application of Hyperoxygenated Fatty Acids in a Surgical Wound of the Umbilical Trocar After Laparoscopic Cholecystectomy With Placement of a Prosthesis in Patients With Risk Factors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana·interventional·Posted Apr 10, 2020·Updated Apr 10, 2020

In Brief

A clinical study evaluating PrevOmega and Physiological saline for Surgical Site Infection. Completed, enrolled 106 participants across 1 site.

Detailed Summary

TITLE: Application of hyperoxygenated fatty acids (PrevOmega) in a surgical wound of the umbilical trocar after laparoscopic cholecystectomy with placement of prostheses in patients with risk factors. OBJECTIVE: This study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (ISQ) and eventration of the trocar orifice (EOT), in patients with risk factors for ISQ AND EOT. METHODS: A prospective, double-blind, randomized study was performed in patients operated on for scheduled cholelithiasis, who also had any of the following risk factors that increase the appearance of SSI or OOT: BMI\> 30kg / m2, Diabetes Mellitus, age\> 65 years and Chronic Obstructive Pulmonary Disease. Group A was administered physiological saline (SSF) at the umbilical trocar level at the end of the intervention versus the administration of PrevOmega to group B. The study was carried out between January 2018 and January 2020 and is registered in the European Database of Clinical Trials with the EudraCT Code: 2018-002260-67.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Site Infection
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 10, 2020
Enrollment StartJan 6, 2018
Primary CompletionJan 4, 2019
Study CompletionJan 4, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.2 years ago

Interventions

PrevOmegaprocedure

The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.

Physiological salineprocedure

The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.