Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair (PICO)

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ClinicalTrials.gov Identifier: NCT03576222

Recruitment Status : Completed

First Posted : July 3, 2018

Last Update Posted : March 31, 2020

Sponsor:

Information provided by (Responsible Party):

JOSE BUENO-LLEDÓ, Hospital Universitario La Fe

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Incisional Hernia	Device: PICO DRESSING Device: MEPORE dressing	Not Applicable

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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:

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).
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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	146 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	PICO dressing prevents surgical site ocurrences after abdominal Wall repair
Masking:	Single (Participant)
Masking Description:	intraoperative use of randomized dressing
Primary Purpose:	Prevention
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
Actual Study Start Date :	May 1, 2017
Actual Primary Completion Date :	June 1, 2018
Actual Study Completion Date :	March 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Wounds and Injuries

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: patients with preventive PICO PICO dressing is used in patients with incisional hernia intraoperatively	Device: PICO DRESSING 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: MEPORE dressing MEPORE dressing

Outcome Measures

Primary Outcome Measures :

questionnaire [ Time Frame: 1 YEAR ]
data about surgical site occurrences

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576222

Locations

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Spain
Hospital Universitari La Fe
Valencia, Spain, 46008

Sponsors and Collaborators

Hospital Universitario La Fe

More Information

Publications of Results:

Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9.

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. Erratum in: J Cardiothorac Surg. 2012;7:37. Camara, Maria-Luisa [added].

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bueno-Lledó J, Franco-Bernal A, Garcia-Voz-Mediano MT, Torregrosa-Gallud A, Bonafé 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.

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Responsible Party:	JOSE BUENO-LLEDÓ, HEAD OF SECTION, Hospital Universitario La Fe
ClinicalTrials.gov Identifier:	NCT03576222
Other Study ID Numbers:	PICO-01
First Posted:	July 3, 2018 Key Record Dates
Last Update Posted:	March 31, 2020
Last Verified:	March 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by JOSE BUENO-LLEDÓ, Hospital Universitario La Fe:


PICO; incisional hernia; surgical site occurrences

Additional relevant MeSH terms:

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Hernia Incisional Hernia Surgical Wound Pathological Conditions, Anatomical	Wounds and Injuries Postoperative Complications Pathologic Processes

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