Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair
Condition: Incisional Hernia
MeSH terms: Hernia; Incisional Hernia; Surgical Wound
Study type: Interventional

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).
    

Intervention name(s): PICO DRESSING; MEPORE dressing
Intervention type(s): Device; Device
Intervention description(s): USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM; MEPORE dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: PICO dressing prevents surgical site ocurrences after abdominal Wall repair
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: PICO; incisional hernia; surgical site occurrences