POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial
NCT ID: NCT04039659
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
110 participants
INTERVENTIONAL
2019-02-01
2021-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The objective of our clinical trial is to evaluate whether the prophylactic use of a negative pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative After signing the informed consent of those patients who meet the inclusion criteria, they will be randomized into two groups to install the PICOⓇ device or conventional dressings on the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied in terms of incidence of surgical site events, stay, etc.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions.
No interventions assigned to this group
PICO group
Patients will carry the device for 7 days uninterrupted until its withdrawal.
Negative-pressure wound therapy (PICO)
After the selection of patients and the signing of the consent, patients will be randomized and the device will be placed to those who belong to the PICO group in the operating room.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Negative-pressure wound therapy (PICO)
After the selection of patients and the signing of the consent, patients will be randomized and the device will be placed to those who belong to the PICO group in the operating room.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario Virgen de la Arrixaca
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ana Delegido Garcia
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ana Delegido García
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen de la Arrixaca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Víctor López López
Role: primary
Ana Delegido García
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
Haley RW, Culver DH, Morgan WM, White JW, Emori TG, Hooton TM. Identifying patients at high risk of surgical wound infection. A simple multivariate index of patient susceptibility and wound contamination. Am J Epidemiol. 1985 Feb;121(2):206-15. doi: 10.1093/oxfordjournals.aje.a113991.
Webster J, Scuffham P, Sherriff KL, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD009261. doi: 10.1002/14651858.CD009261.pub2.
Kilpadi DV, Cunningham MR. Evaluation of closed incision management with negative pressure wound therapy (CIM): hematoma/seroma and involvement of the lymphatic system. Wound Repair Regen. 2011 Sep-Oct;19(5):588-96. doi: 10.1111/j.1524-475X.2011.00714.x.
Malmsjo M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014 Apr 2;14:e15. eCollection 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-1-6-HCUVA
Identifier Type: -
Identifier Source: org_study_id