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Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.

NCT04341805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2020-04-10

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

PROCEDURE

PrevOmega

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

PROCEDURE

Physiological saline

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

Sponsors & Collaborators

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    lead OTHER

Principal Investigators

  • Laura Armañanzas · HGUE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-06
Primary Completion
2019-01-04
Completion
2020-01-04

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341805 on ClinicalTrials.gov