Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair
キーワード
概要
説明
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).
日付
最終確認済み: | 02/29/2020 |
最初に提出された: | 06/08/2018 |
提出された推定登録数: | 07/01/2018 |
最初の投稿: | 07/02/2018 |
最終更新が送信されました: | 03/26/2020 |
最終更新日: | 03/30/2020 |
実際の研究開始日: | 04/30/2017 |
一次完了予定日: | 05/31/2018 |
研究完了予定日: | 03/24/2020 |
状態または病気
介入/治療
Device: patients with preventive PICO
Device: patients with preventive MEPORE
段階
アームグループ
腕 | 介入/治療 |
---|---|
Active Comparator: patients with preventive PICO PICO dressing is used in patients with incisional hernia intraoperatively | Device: patients with preventive PICO 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: patients with preventive MEPORE MEPORE dressing |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | 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. |
結果
主な結果の測定
1. questionnaire [1 YEAR]