NCT03576222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

June 9, 2018

Last Update Submit

March 27, 2020

Conditions

Incisional Hernia

Keywords

PICO; incisional hernia; surgical site occurrences

Outcome Measures

Primary Outcomes (1)

  • questionnaire

    data about surgical site occurrences

    1 YEAR

Study Arms (2)

patients with preventive PICO

ACTIVE COMPARATOR

PICO dressing is used in patients with incisional hernia intraoperatively

Device: PICO DRESSING

patients with preventive MEPORE

PLACEBO COMPARATOR

MEPORE dressing is used in patients with incisional hernia intraoperatively

Device: MEPORE dressing

Interventions

PICO DRESSINGDEVICE

USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM

patients with preventive PICO
MEPORE dressingDEVICE

MEPORE dressing

patients with preventive MEPORE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari La Fe

Valencia, 46008, Spain

Location

Related Publications (12)

  • 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.

    PMID: 17106382RESULT

  • 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.

    PMID: 25903674RESULT

  • 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.

    PMID: 23742125RESULT

  • 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.

    PMID: 22145641RESULT

  • 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.

    PMID: 23883481RESULT

  • 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.

    PMID: 22015748RESULT

  • 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.

    PMID: 24106562RESULT

  • 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.

    PMID: 21868417RESULT

  • 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.

    PMID: 19460818RESULT

  • 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.

    PMID: 23127793RESULT

  • 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.

    PMID: 18840089RESULT

  • 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.

    PMID: 33201116DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
intraoperative use of randomized dressing
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: PICO dressing prevents surgical site ocurrences after abdominal Wall repair
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HEAD OF SECTION

Study Record Dates

First Submitted

June 9, 2018

First Posted

July 3, 2018

Study Start

May 1, 2017

Primary Completion

June 1, 2018

Study Completion

March 25, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

ES(1)