Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair

Incisional Hernia Clinical Trial

— PICO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576222
• Other study ID #: PICO-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 25, 2020

Study information

• Verified date: March 2020
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 25, 2020
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Surgical Wound

Intervention

Device:
• PICO DRESSING
USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
• MEPORE dressing
MEPORE dressing

Locations

Country	Name	City	State
Spain	Hospital Universitari La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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 — View Citation

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 — View Citation

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. — View Citation

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 improvemen — View Citation

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 — View Citation

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. — View Citation

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

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. — View Citation

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. d — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire	data about surgical site occurrences	1 YEAR