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

NCT04341805 | Completed

• 1 other identifier: AGHO-MYL01/2020
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy

  1 year

Secondary Outcomes (1)

• Trocar hole eventration

  1 year

Study Arms (2)

Group A. Physiological saline.

ACTIVE COMPARATOR

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

Group B. Solution hyperoxygenated fatty acids

EXPERIMENTAL

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

Interventions

PrevOmega PROCEDURE

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

Group B. Solution hyperoxygenated fatty acids

Physiological saline PROCEDURE

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

Group A. Physiological saline.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Conversion to laparotomy during the intervention
• Non-acceptance by the patient to participate in the study,
• Loss to follow-up.

Sponsors & Collaborators

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

Study Sites (1)

Marta

Elche, Alicante, 03203, Spain

Location

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MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Armañanzas

  HGUE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: January 6, 2018
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)