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

April 9, 2020 updated by: Marta Bellón, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Marta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A. Physiological saline.
The surgical procedure in group A consisted of the placement of a 6.4cm diameter circular prosthesis (BARD Hernia Patch) at the intra-abdominal level. Subsequently, the liquid contained in the 10 ml opaque vial was administered (Ecolav Physiological Washing Serum 0.9%, (SSF).
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.
Experimental: Group B. Solution hyperoxygenated fatty acids
The surgical procedure in group B consisted of the placement of a 6.4cm diameter circular prosthesis (BARD Hernia Patch) at the intra-abdominal level. Subsequently, the liquid contained in the 10 ml opaque vial (AGHO solution) was administered according to randomization.
Procedure: PrevOmega
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 1 year
Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trocar hole eventration
Time Frame: 1 year
Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Laura Armañanzas, HGUE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2018

Primary Completion (Actual)

January 4, 2019

Study Completion (Actual)

January 4, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGHO-MYL01/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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