An interventional study of PICO DRESSING and MEPORE dressing in Incisional Hernia, sponsored by Hospital Universitario La Fe. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Hospital Universitario La Fe · Not applicable, Interventional, and Prevention
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.
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:
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:
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:
Dependent (study outcomes)
Independent
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).
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 146 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Hospital Universitario La Fe is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PICO dressing is used in patients with incisional hernia intraoperatively
Device: PICO DRESSING
MEPORE dressing is used in patients with incisional hernia intraoperatively
Device: MEPORE dressing
USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
MEPORE dressing
questionnaire
data about surgical site occurrences
Time frame: 1 YEAR
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Fe