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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrevOmega | Procedure | The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Trocar hole eventration | Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy | 1 year |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Armañanzas | HGUE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marta | Elche | Alicante | 03203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| 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. |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |