Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair (PICO)

March 27, 2020 updated by: JOSE BUENO-LLEDÓ, Hospital Universitario La Fe

Prospective, Randomized, Comparative Study About Effects of Preventive Negative Pressure Therapy With PICO or Standard Care Dressing (MEPORE) on Surgical Wounds After Large Incisional Hernia Repair

To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing repair of large incisional hernias, after the prophylactic application of a single-use negative pressure therapy dressing (PICO), versus a conventional dressing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis The preventive use of single-use PICO dressing reduces the complications of the surgical wound (infection and dehiscence of the surgical wound) in patients after large incisional hernia repair.

Objectives

Primary:

To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing eventration surgery, after the prophylactic application of a single-use negative pressure therapy (NPT) dressing, as opposed to a conventional dressing.

Secondary:

  • To report the incidence of wound infection and dehiscence during the patient's admission, at 7 days, 15 days and month after surgical repair applying a conventional dressing (MEPORE) or PICO dressing.
  • To quantify economic costs applying a PICO dressing versus a MEPORE dressing.

Methods:

Selection of patients Collection of the sample will be made in the Abdominal Wall Surgery Unit (La Fe Hospital), according to the inclusion and exclusion criteria. The surgeon will explain to the patient the objectives of the study and will give him an informed consent and will answer all the doubts about the study.

Patients will be assigned to two groups in a 1: 1 ratio. Assignment of each patient to the different groups will be done using a randomized method according to the following distribution:

  • Group A, it will be applied the dressing object of study (PICO)
  • Group B, it will be applied the conventional dressing (MEPORE).

Data collection and Study variables

For each patient, the data collection notebook designed for this purpose must be completed, which includes the following study variables:

  1. Dependent (study outcomes)

    • Infection and dehiscence of surgical wound. These variables will be assessed throughout the admission and at 7 and 30 days from the hernia repair, during hospital stay, and at 15 days in the Unit.
    • Variables related to direct costs (hospital stay, material, antibiotic use, operating room use, etc). Other variables related to indirect costs (time of cure by nursing).

  2. Independent

    • Demographic data: age, sex, BMI.
    • Classification ASA (American Society of Anesthesiologists)
    • Risk factors abour surgical wound complications: drainage, preoperative chemotherapy, preoperative radiotherapy, Diabetes Mellitus, cardiovascular disease, immunosuppressive treatment, active smoking, obesity, hypertension, inflammatory bowel disease.

Number of subjects 150 patients undergoing hernia repair of large incisional hernia (types W2 or W3 according to EHS classification) will be included in La Fe Hospital in Valencia from January 2017 until the recruitment of the entire sample (estimated in December 2018).

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46008
        • Hospital Universitari La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years old (men and women).
  • To give his consent to participation in the study.
  • To have surgical prosthetic repair of large incisional hernia (type W2 or W3).
  • Patients admitted to the 6th floor, G tower (Unit of Abdominal Wall surgery).

Exclusion Criteria:

  • Patients with immediate reintervention of abdominal surgery (less than 30 days from the first surgery).
  • Patients after emergency surgery.
  • Patients with biological prosthesis.
  • Pregnancy and lactation.
  • Hepatic cirrhosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: patients with preventive PICO
PICO dressing is used in patients with incisional hernia intraoperatively
Device: PICO DRESSING
USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
PLACEBO_COMPARATOR: patients with preventive MEPORE
MEPORE dressing is used in patients with incisional hernia intraoperatively
Device: MEPORE dressing
MEPORE dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire
Time Frame: 1 YEAR
data about surgical site occurrences
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

March 25, 2020

Study Registration Dates

First Submitted

June 9, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (ACTUAL)

July 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICO-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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