Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.
NCT ID: NCT04341805
Last Updated: 2020-04-10
Study Results
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Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2018-01-06
2020-01-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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).
Physiological saline
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.
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.
PrevOmega
The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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).
* Conversion to laparotomy during the intervention
* Non-acceptance by the patient to participate in the study,
* Loss to follow-up.
18 Years
90 Years
ALL
No
Sponsors
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
OTHER
Responsible Party
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Marta Bellón
Physician
Principal Investigators
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Laura Armañanzas
Role: STUDY_DIRECTOR
HGUE
Locations
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Marta
Elche, Alicante, Spain
Countries
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References
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Other Identifiers
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AGHO-MYL01/2020
Identifier Type: -
Identifier Source: org_study_id
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