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

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341805
• Other study ID #: AGHO-MYL01/2020
• Status: Completed
• Phase: N/A
• Start date: January 6, 2018
• Est. completion date: January 4, 2020

Study information

• Verified date: April 2020
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 4, 2020
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection

Intervention

Procedure:
• PrevOmega
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.
• Physiological saline
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.

Locations

Country	Name	City	State
Spain	Marta	Elche	Alicante

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy	1 year
Secondary	Trocar hole eventration	Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy	1 year