Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04341805
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '1 year', 'description': 'Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy'}], 'secondaryOutcomes': [{'measure': 'Trocar hole eventration', 'timeFrame': '1 year', 'description': 'Trocar hole eventration rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '15091147', 'type': 'BACKGROUND', 'citation': 'Bowler PG, Jones SA, Walker M, Parsons D. 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Prophylactic mesh vs suture in the closure of the umbilical trocar site after laparoscopic cholecystectomy in high-risk patients for incisional hernia. A randomized clinical trial. J Am Coll Surg. 2014 May;218(5):960-8. doi: 10.1016/j.jamcollsurg.2014.01.049. Epub 2014 Feb 18.'}, {'pmid': '21255770', 'type': 'BACKGROUND', 'citation': 'Comajuncosas J, Vallverdu H, Orbeal R, Pares D. [Trocar site incisional hernia in laparoscopic surgery]. Cir Esp. 2011 Feb;89(2):72-6. doi: 10.1016/j.ciresp.2010.08.007. Epub 2011 Jan 20. Spanish.'}, {'pmid': '25618025', 'type': 'BACKGROUND', 'citation': 'Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25.'}, {'pmid': '11936376', 'type': 'BACKGROUND', 'citation': 'Mangram AJ. A brief overview of the 1999 CDC Guideline for the Prevention of Surgical Site Infection. Centers for Disease Control and Prevention. J Chemother. 2001 Nov;13 Spec No 1(1):35-9. doi: 10.1179/joc.2001.13.Supplement-2.35.'}, {'pmid': '25376070', 'type': 'BACKGROUND', 'citation': 'Anderson DJ, Podgorny K, Berrios-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S66-88. doi: 10.1017/s0899823x00193869. No abstract available.'}, {'pmid': '23327981', 'type': 'BACKGROUND', 'citation': 'Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.'}, {'pmid': '24670166', 'type': 'BACKGROUND', 'citation': 'Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801.'}, {'pmid': '27915053', 'type': 'BACKGROUND', 'citation': 'Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74. doi: 10.1016/j.jamcollsurg.2016.10.029. Epub 2016 Nov 30. No abstract available.'}, {'pmid': '28139389', 'type': 'BACKGROUND', 'citation': 'Leaper DJ, Edmiston CE. World Health Organization: global guidelines for the prevention of surgical site infection. J Hosp Infect. 2017 Feb;95(2):135-136. doi: 10.1016/j.jhin.2016.12.016. Epub 2016 Dec 24. No abstract available.'}, {'pmid': '28145967', 'type': 'BACKGROUND', 'citation': 'Brathwaite S, Latchana N, Esemuede I, Harzman A, Husain S. Risk Factors for Surgical Site Infection in Open and Laparoscopic Hartmann Closure: A Multivariate Analysis. Surg Laparosc Endosc Percutan Tech. 2017 Feb;27(1):51-53. doi: 10.1097/SLE.0000000000000365.'}, {'pmid': '22591890', 'type': 'BACKGROUND', 'citation': 'Rangel-Huerta OD, Aguilera CM, Mesa MD, Gil A. Omega-3 long-chain polyunsaturated fatty acids supplementation on inflammatory biomakers: a systematic review of randomised clinical trials. Br J Nutr. 2012 Jun;107 Suppl 2:S159-70. doi: 10.1017/S0007114512001559.'}, {'pmid': '21318557', 'type': 'BACKGROUND', 'citation': 'Hidalgo MP, Ferrero EH, Ortiz MA, Castillo JM, Hidalgo AG. Incisional hernia in patients at risk: can it be prevented? Hernia. 2011 Aug;15(4):371-5. doi: 10.1007/s10029-011-0794-0. Epub 2011 Feb 12.'}, {'pmid': '19262985', 'type': 'BACKGROUND', 'citation': 'El-Khadrawy OH, Moussa G, Mansour O, Hashish MS. Prophylactic prosthetic reinforcement of midline abdominal incisions in high-risk patients. Hernia. 2009 Jun;13(3):267-74. doi: 10.1007/s10029-009-0484-3. Epub 2009 Mar 5.'}, {'pmid': '18492730', 'type': 'BACKGROUND', 'citation': 'Moreno-Sanz C, Picazo-Yeste JS, Manzanera-Diaz M, Herrero-Bogajo ML, Cortina-Oliva J, Tadeo-Ruiz G. Prevention of trocar site hernias: description of the safe port plug technique and preliminary results. Surg Innov. 2008 Jun;15(2):100-4. doi: 10.1177/1553350608318789.'}, {'pmid': '15545574', 'type': 'BACKGROUND', 'citation': 'Tonouchi H, Ohmori Y, Kobayashi M, Kusunoki M. Trocar site hernia. Arch Surg. 2004 Nov;139(11):1248-56. doi: 10.1001/archsurg.139.11.1248.'}, {'pmid': '24232668', 'type': 'BACKGROUND', 'citation': 'Desbois AP, Lawlor KC. Antibacterial activity of long-chain polyunsaturated fatty acids against Propionibacterium acnes and Staphylococcus aureus. Mar Drugs. 2013 Nov 13;11(11):4544-57. doi: 10.3390/md11114544.'}, {'pmid': '22150831', 'type': 'BACKGROUND', 'citation': 'Mil-Homens D, Bernardes N, Fialho AM. The antibacterial properties of docosahexaenoic omega-3 fatty acid against the cystic fibrosis multiresistant pathogen Burkholderia cenocepacia. FEMS Microbiol Lett. 2012 Mar;328(1):61-9. doi: 10.1111/j.1574-6968.2011.02476.x. Epub 2012 Jan 6.'}, {'pmid': '25003455', 'type': 'BACKGROUND', 'citation': 'McCullough MC, Chu CK, Duggal CS, Losken A, Carlson GW. Antibiotic Prophylaxis and Resistance in Surgical Site Infection After Immediate Tissue Expander Reconstruction of the Breast. Ann Plast Surg. 2016 Nov;77(5):501-505. doi: 10.1097/SAP.0000000000000275.'}, {'pmid': '26866217', 'type': 'BACKGROUND', 'citation': 'Cattoir V. Mechanisms of Antibiotic Resistance. 2016 Feb 10. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: Basic Biology to Clinical Manifestations [Internet]. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016-. Available from http://www.ncbi.nlm.nih.gov/books/NBK333414/'}, {'pmid': '27616769', 'type': 'BACKGROUND', 'citation': 'Frieri M, Kumar K, Boutin A. Antibiotic resistance. J Infect Public Health. 2017 Jul-Aug;10(4):369-378. doi: 10.1016/j.jiph.2016.08.007. Epub 2016 Sep 6.'}, {'pmid': '22854528', 'type': 'BACKGROUND', 'citation': 'Minar E, Schillinger M. Innovative technologies for SFA occlusions: drug coated balloons in SFA lesions. J Cardiovasc Surg (Torino). 2012 Aug;53(4):481-6.'}, {'pmid': '15739656', 'type': 'BACKGROUND', 'citation': 'Meaume S, Colin D, Barrois B, Bohbot S, Allaert FA. Preventing the occurrence of pressure ulceration in hospitalised elderly patients. J Wound Care. 2005 Feb;14(2):78-82. doi: 10.12968/jowc.2005.14.2.26741.'}, {'pmid': '18564784', 'type': 'RESULT', 'citation': 'Maicas VT, Rochina IJ. [Linoleic acid emulsion on the peri-lesion skin of venal ulcers. Action and cicatrizant effect. Corpus study]. Rev Enferm. 2008 Apr;31(4):26-32. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'TITLE:\n\nApplication 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.\n\nOBJECTIVE: 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.\n\nMETHODS: 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 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:\n\n* Obesity with body mass index (BMI)\\> 30kg / m2\n* Diabetes Mellitus (insulin dependent or oral antidiabetic takers)\n* Age (\\> 65 years)\n* Chronic Obstructive Pulmonary Disease (COPD in treatment with inhalers).\n\nExclusion Criteria:\n\n* Non-compliance with the inclusion criteria\n* Conversion to laparotomy during the intervention\n* Non-acceptance by the patient to participate in the study,\n* Loss to follow-up.'}, 'identificationModule': {'nctId': 'NCT04341805', 'briefTitle': 'Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AGHO-MYL01/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A. Physiological saline.', '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).', 'interventionNames': ['Procedure: Physiological saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group B. Solution hyperoxygenated fatty acids', '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.', 'interventionNames': ['Procedure: PrevOmega']}], 'interventions': [{'name': 'PrevOmega', 'type': 'PROCEDURE', 'description': 'The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.', 'armGroupLabels': ['Group B. Solution hyperoxygenated fatty acids']}, {'name': 'Physiological saline', 'type': 'PROCEDURE', 'description': 'The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.', 'armGroupLabels': ['Group A. Physiological saline.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Marta', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'overallOfficials': [{'name': 'Laura Armañanzas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HGUE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Marta Bellón', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}