Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair
NCT ID: NCT03576222
Last Updated: 2020-03-31
Study Results
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Basic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2017-05-01
2020-03-25
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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patients with preventive PICO
PICO dressing is used in patients with incisional hernia intraoperatively
PICO DRESSING
USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
patients with preventive MEPORE
MEPORE dressing is used in patients with incisional hernia intraoperatively
MEPORE dressing
MEPORE dressing
Interventions
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PICO DRESSING
USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
MEPORE dressing
MEPORE dressing
Eligibility Criteria
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Inclusion Criteria
* 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 after emergency surgery.
* Patients with biological prosthesis.
* Pregnancy and lactation.
* Hepatic cirrhosis.
18 Years
90 Years
ALL
Yes
Sponsors
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Hospital Universitario La Fe
OTHER
Responsible Party
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JOSE BUENO-LLEDÓ
HEAD OF SECTION
Locations
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Hospital Universitari La Fe
Valencia, , Spain
Countries
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References
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Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.
Stannard JP, Zane Atkins B, O'Malley D, Singh H, Bernstein B, Fahey M, Masden D, Attinger CE. use of negative pressure therapy on closed surgical incisions: a case series. Wounds. 2009 Aug;21(8):221-8.
Arroyo AA, Casanova PL, Soriano JV, Torra I Bou JE. Open-label clinical trial comparing the clinical and economic effectiveness of using a polyurethane film surgical dressing with gauze surgical dressings in the care of post-operative surgical wounds. Int Wound J. 2015 Jun;12(3):285-92. doi: 10.1111/iwj.12099. Epub 2013 Jun 7.
Colli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011 Dec 6;6:160. doi: 10.1186/1749-8090-6-160.
Pellino G, Sciaudone G, Candilio G, Campitiello F, Selvaggi F, Canonico S. Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial. Surg Innov. 2014 Apr;21(2):204-12. doi: 10.1177/1553350613496906. Epub 2013 Jul 24.
de Tullio D, Biondin V, Occhionorelli S. When a postsurgical dehiscence becomes a serious problem. Adv Skin Wound Care. 2011 Nov;24(11):503-6. doi: 10.1097/01.ASW.0000407646.05209.e2.
Ingargiola MJ, Daniali LN, Lee ES. Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Eplasty. 2013 Sep 20;13:e49. eCollection 2013.
Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25.
Atkins BZ, Wooten MK, Kistler J, Hurley K, Hughes GC, Wolfe WG. Does negative pressure wound therapy have a role in preventing poststernotomy wound complications? Surg Innov. 2009 Jun;16(2):140-6. doi: 10.1177/1553350609334821. Epub 2009 May 21.
Cima R, Dankbar E, Lovely J, Pendlimari R, Aronhalt K, Nehring S, Hyke R, Tyndale D, Rogers J, Quast L; Colorectal Surgical Site Infection Reduction Team. Colorectal surgery surgical site infection reduction program: a national surgical quality improvement program--driven multidisciplinary single-institution experience. J Am Coll Surg. 2013 Jan;216(1):23-33. doi: 10.1016/j.jamcollsurg.2012.09.009. Epub 2012 Nov 2.
Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S51-61. doi: 10.1086/591064. No abstract available.
Bueno-Lledo J, Franco-Bernal A, Garcia-Voz-Mediano MT, Torregrosa-Gallud A, Bonafe S. Prophylactic Single-use Negative Pressure Dressing in Closed Surgical Wounds After Incisional Hernia Repair: A Randomized, Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1081-1086. doi: 10.1097/SLA.0000000000004310.
Other Identifiers
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PICO-01
Identifier Type: -
Identifier Source: org_study_id
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