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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PrevOmega
Physiological saline
Sponsored by
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A. Physiological saline.

Group B. Solution hyperoxygenated fatty acids

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Trocar hole eventration
Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy

Full Information

First Posted
April 7, 2020
Last Updated
April 9, 2020
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT04341805
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2018 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
January 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A. Physiological saline.
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group B. Solution hyperoxygenated fatty acids
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PrevOmega
Intervention Description
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.
Intervention Type
Procedure
Intervention Name(s)
Physiological saline
Intervention Description
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Trocar hole eventration
Description
Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Armañanzas
Organizational Affiliation
HGUE
Official's Role
Study Director
Facility Information:
Facility Name
Marta
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.

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