Clinical trial NCT04341805: Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients with ages between 18 and 90 years who underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and who also presented any of the following risk factors for SSI or EOT were included:

* Obesity with body mass index (BMI)\> 30kg / m2
* Diabetes Mellitus (insulin dependent or oral antidiabetic takers)
* Age (\> 65 years)
* Chronic Obstructive Pulmonary Disease (COPD in treatment with inhalers).

Exclusion Criteria:

* Non-compliance with the inclusion criteria
* Conversion to laparotomy during the intervention
* Non-acceptance by the patient to participate in the study,
* Loss to follow-up.

Primary outcomes:
measure: Surgical site infection
timeFrame: 1 year
Secondary outcomes:
measure: Trocar hole eventration
timeFrame: 1 year
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Marta
state: Alicante
Study officials:
affiliation: HGUE
name: Laura Armañanzas
role: STUDY_DIRECTOR
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