POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial

NCT04039659 | Unknown DMC

• 1 other identifier: 2019-1-6-HCUVA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate whether the prophylactic use of a negativa 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

Conditions

Liver Transplant; Complications

Keywords

wound complications; negative-pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• Incidence rate of surgical site

  Any complication of surgical site will be registered

  30 days after surgery

Secondary Outcomes (2)

• Quality of life of transplantation patient

  6 months

• Nosocomial infection rate

  30 days after surgery (3rd, 7th, 15th and 30th post trasplant)

Study Arms (2)

Control Group

NO INTERVENTION

Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions.

PICO group

ACTIVE COMPARATOR

Patients will carry the device for 7 days uninterrupted until its withdrawal.

Device: Negative-pressure wound therapy (PICO)

Interventions

Negative-pressure wound therapy (PICO) DEVICE

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.

PICO group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes aged between 18 and 70 years included in the waiting list for liver transplantation by the committee of the Virgen de la Arrixaca University Hospital.

You may not qualify if:

• To have been rejected for liver transplantation by said committee

Sponsors & Collaborators

• Hospital Universitario Virgen de la Arrixaca: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 1656747 BACKGROUND

• 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.

  PMID: 4014116 BACKGROUND

• 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.

  PMID: 22513974 BACKGROUND

• 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.

  PMID: 22092797 BACKGROUND

• 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.

  PMID: 24741386 BACKGROUND

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Ana Delegido García

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Víctor López López

CONTACT

+34 637519516; victorrelopez@gmail.com

Ana Delegido García

CONTACT

+ 34 686556188; ana.delegido.garcia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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 over the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: July 31, 2019
• Study Start: February 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available when the results are published.

Locations

ES (1)