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

POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant (PONILITRANS Study): a Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Liver Transplant; Complications
• Intervention / Treatment: Device: Negative-pressure wound therapy (PICO)

Detailed Description

Postoperative complications of surgical wounds are frequent after surgical procedures, even more in the context of liver transplantation given the necessary immunosuppression, high surgical time, high hospital stay and intensive care, politransfusions, etc. Negative pressure therapy is well established for the treatment of open wounds, its use having been recently indicated on closed surgical wounds. The evidence to justify this intervention is still limited.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Recruiting
      • Hospital Clínico Universitario Virgen de la Arrixaca
      • Contact: Víctor López López; Phone Number: +34 637519516; Email: victorrelopez@gmail.com
      • Contact: Ana Delegido García; Phone Number: +34 686556188; Email: ana.delegido.garcia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• To have been rejected for liver transplantation by said committee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions.
Active Comparator: PICO group; Patients will carry the device for 7 days uninterrupted until its withdrawal.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of surgical site	Any complication of surgical site will be registered	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of transplantation patient	We will use Cardiff Wound Impact Schedule to evaluate the possible improvement in the quality of life of transplantation patients derived from the decrease in the requirement of health resources.	6 months
Nosocomial infection rate	To verify the change in rates of nosocomial infections in the context of liver transplantation.	30 days after surgery (3rd, 7th, 15th and 30th post trasplant)

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen de la Arrixaca
• Investigators: Principal Investigator: Ana Delegido García, Hospital Clínico Universitario Virgen de la Arrixaca

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: wound complications; negative-pressure wound therapy
• Other Study ID Numbers: 2019-1-6-HCUVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All documentation related to the study will remain stored in the Investigator's Archive, in the participating center, in the custody of the Principal Investigator until the end of it. Once the study is finished, the documentation will be indexed and will go to the general file of the center.
• IPD Sharing Time Frame: Data will be available when the results are published.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No