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Surgical Site InfectionNCT04345809

Effect of Prophylactic Prosthesis Placement With Versus Without Omega-3 at the Umbilical Trocar Level on Surgical Site Infection and Herniation After Laparoscopic Cholecystectomy in Patients With Risk Factors.

An observational study of Surgical Site Infection, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TITLE: Effect of prophylactic prosthesis placement with versus without omega-3 at the umbilical trocar level on surgical site infection and herniation after laparoscopic cholecystectomy in patients with risk factors. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Surgical Site Infection
What is being tested?
MESH WHIT OMEGA-3 and MESH WITHOUT OMEGA-3
Type of treatment
Surgery or procedure
How many people
95 participants
Where
No sites listed yet
Study dates
Jan 2016to Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients were between the ages of 18 and 90 years, underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and had one of the following risk factors that increase the occurrence of SSI or TSIH, included in general surgery consultations.

Who may be able to join

  • The included patients were between the ages of 18 and 90 years, underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and had one of the following risk factors that increase the occurrence of SSI or TSIH:
  • Obesity: with a body mass index (BMI) > 30 kg/m2.
  • Diabetes Mellitus (insulin dependent or who take oral antidiabetic drugs),
  • Age > 65 years and
  • COPD treated with inhalers.

Who cannot join

  • Nonfulfillment of the inclusion criteria.
  • Conversion to laparotomy during the surgical procedure
  • Non-acceptance of participation in the study by the patient
  • Loss to follow-up.

About this study

TITLE:

Effect of prophylactic prosthesis placement with versus without omega-3 at the umbilical trocar level on surgical site infection and herniation after laparoscopic cholecystectomy in patients with risk factors.

OBJECTIVE: To evaluate whether the placement of a synthetic prosthesis with omega-3 in its composition at the level of the umbilical trocar after laparoscopic cholecystectomy versus the placement of a synthetic umbilical prosthesis without omega-3 in its composition decreases the rate of surgical site infection (SSI) and trocar site hernia (TSH) in patients with risk factors for infection and herniation.

Read the detailed description

METHODS: A prospective study was conducted with 2 consecutive series of patients operated on for cholelithiasis who also had some of the following risk factors that increase the occurrence of SSI or TSH: BMI > 30 kg/m2, diabetes mellitus, age > 65 years and chronic obstructive pulmonary disease. A circular prosthesis with an omega-3 coating was placed in patients in group A, and a prosthesis without omega-3 in its composition was placed in patients in group B. The main variables evaluated were the occurrence of SSI and TSH.

Being tested
MESH WHIT OMEGA-3, MESH WITHOUT OMEGA-3
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MESH WHIT OMEGA-3Procedure or surgery

    Mesh placement with Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.

  • MESH WITHOUT OMEGA-3Procedure or surgery

    Mesh placement without Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.

Study groups in NCT04345809
Study groupRoleWhat they receive
GROUP A. MESH WITH OMEGA-3Group A - 6.4-cm diameter circular prosthesis C-QUR V-Patch with an omega-3 coating
Receives: Procedure: MESH WHIT OMEGA-3
GROUP B. MESH WITHOUT OMEGA-3Group B - 6.4-cm diameter circular prosthesis BARD Hernia Patch , without omega-3 in its composition
Receives: Procedure: MESH WITHOUT OMEGA-3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SSI

    Surgical Site Infection.

    Measured: 1 year

  2. TSIH

    Trocar site incisional hernia.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study startJan 2016
  3. Primary completionJan 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345809
Sponsor's protocol ID
AGHO MYL PRELIMI
Status last verified
Apr 2020
First submitted
11 Apr 2020
Last updated
14 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All individual patient data may be used by other researchers in terms of advancing research in this field.

Publications

  • Tomioka K, Murakami M, Fujimori A, Watanabe M, Koizumi T, Goto S, Otsuka K, Aoki T. Risk Factors for Transumbilical Wound Complications in Laparoscopic Gastric and Colorectal Surgery. In Vivo. 2017 Sep-Oct;31(5):943-948. doi: 10.21873/invivo.11151.

    PubMed 28882963

  • Bowler PG, Jones SA, Walker M, Parsons D. Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. J Burn Care Rehabil. 2004 Mar-Apr;25(2):192-6. doi: 10.1097/01.bcr.0000112331.72232.1b.

    PubMed 15091147

  • Sanders D, Lambie J, Bond P, Moate R, Steer JA. An in vitro study assessing the effect of mesh morphology and suture fixation on bacterial adherence. Hernia. 2013 Dec;17(6):779-89. doi: 10.1007/s10029-013-1124-5. Epub 2013 Jun 19.

    PubMed 23780573

  • Lai NM, Chaiyakunapruk N, Lai NA, O'Riordan E, Pau WS, Saint S. Catheter impregnation, coating or bonding for reducing central venous catheter-related infections in adults. Cochrane Database Syst Rev. 2016 Mar 16;3(3):CD007878. doi: 10.1002/14651858.CD007878.pub3.

    PubMed 26982376

  • 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.

    PubMed 22854528

  • Fernandez-Gutierrez M, Olivares E, Pascual G, Bellon JM, San Roman J. Low-density polypropylene meshes coated with resorbable and biocompatible hydrophilic polymers as controlled release agents of antibiotics. Acta Biomater. 2013 Apr;9(4):6006-18. doi: 10.1016/j.actbio.2012.12.012. Epub 2012 Dec 20.

    PubMed 23261925

  • Chopra I. The increasing use of silver-based products as antimicrobial agents: a useful development or a cause for concern? J Antimicrob Chemother. 2007 Apr;59(4):587-90. doi: 10.1093/jac/dkm006. Epub 2007 Feb 16.

    PubMed 17307768

  • 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.

    PubMed 18564784

  • Iannitti DA, Hope WW, Norton HJ, Lincourt AE, Millikan K, Fenoglio ME, Moskowitz M. Technique and outcomes of abdominal incisional hernia repair using a synthetic composite mesh: a report of 455 cases. J Am Coll Surg. 2008 Jan;206(1):83-8. doi: 10.1016/j.jamcollsurg.2007.07.030. Epub 2007 Oct 18.

    PubMed 18155572

  • Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.

    PubMed 23859304

  • Sugerman HJ, Kellum JM Jr, Reines HD, DeMaria EJ, Newsome HH, Lowry JW. Greater risk of incisional hernia with morbidly obese than steroid-dependent patients and low recurrence with prefascial polypropylene mesh. Am J Surg. 1996 Jan;171(1):80-4. doi: 10.1016/S0002-9610(99)80078-6.

    PubMed 8554156

  • Sauerland S, Korenkov M, Kleinen T, Arndt M, Paul A. Obesity is a risk factor for recurrence after incisional hernia repair. Hernia. 2004 Feb;8(1):42-6. doi: 10.1007/s10029-003-0161-x. Epub 2003 Sep 6.

    PubMed 13680307

  • Anthony T, Bergen PC, Kim LT, Henderson M, Fahey T, Rege RV, Turnage RH. Factors affecting recurrence following incisional herniorrhaphy. World J Surg. 2000 Jan;24(1):95-100;discussion 101. doi: 10.1007/s002689910018.

    PubMed 10594211

  • 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.

    PubMed 21255770

  • Arroyo A, Garcia P, Perez F, Andreu J, Candela F, Calpena R. Randomized clinical trial comparing suture and mesh repair of umbilical hernia in adults. Br J Surg. 2001 Oct;88(10):1321-3. doi: 10.1046/j.0007-1323.2001.01893.x.

    PubMed 11578284

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Site Infection, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SSI (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345809, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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