Clinical trial NCT03576222: Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Keywords: PICO; incisional hernia; surgical site occurrences
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PICO dressing prevents surgical site ocurrences after abdominal Wall repair
Primary purpose: PREVENTION

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: questionnaire
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari La Fe
Study officials:
References:
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