Surgical Site Infection
Conditions
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.
Interventions
PROCEDUREPrevOmega
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.
PROCEDUREPhysiological saline
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 1 year | Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trocar hole eventration | 1 year | Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy |
Countries
Spain
Outcome results
None listed