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Repair of Large Incisional Hernias - To Drain or Not to Drain Randomised Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163460
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Universidade Estadual do Oeste do Paraná

Brief Summary:
The aim of this study was to perform a randomised clinical trial comparing the use of closed-suction tubular drains and progressive tension sutures in individuals with large incisional hernias subjected to onlay mesh repair to evaluate the occurrence of seroma and surgical wound infection after surgery.

Condition or disease Intervention/treatment Phase
Ventral Hernia Procedure: Drain Procedure: Progressive Tension Sutures Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between the Use of Tubular Drains in Closed Suction System and the Use of Progressive Tension Sutures in Prevention of Infection and Seromas After Surgical Repair of Large Incisional Hernias
Study Start Date : May 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Drain
In group 1(Drain), a 4.8 mm diameter continuous closed-suction tubular drain : was placed between the aponeurosis and the subcutaneous tissue caudally to the incision.
Procedure: Drain
In group 1, a 4.8 mm diameter continuous closed-suction tubular drain (Medsharp Ind.Com.Prod.Hosp.Ltda - reg. MS (Ministério da Saúde [Health Ministry registry]): 80267170001) was placed between the aponeurosis and the subcutaneous tissue caudally to the incision.
Other Name: 4.8 mm diameter surgical closed-suction tubular drain

Experimental: Progressive Tension Sutures
Drains were not used in group 2, but separate absorbable polyglactin 920 2/0 sutures were placed from the subcutaneous mesh to the aponeurosis every 2 cm by means of the progressive tension suture (or Quilting Sutures) technique, as described by Pollock et al
Procedure: Progressive Tension Sutures
Drains were not used in group 2, but separate absorbable polyglactin 920 2/0 sutures were placed from the subcutaneous mesh to the aponeurosis every 2 cm by means of the progressive tension suture (or Quilting Sutures) technique, as described by Pollock et al
Other Name: Quilting Sutures, Baroudi Sutures




Primary Outcome Measures :
  1. Seroma [ Time Frame: 1 month ]
    Clinical and/or radiological diagnosis of seroma until 1 month


Secondary Outcome Measures :
  1. Infection [ Time Frame: 1 month ]
    Surgical wound infection was prospectively defined according to the criteria formulated by the Centers for Disease Control and Prevention (CDC) in the Guideline for Prevention of Surgical Site Infection, 1999 in the first month postoperative


Other Outcome Measures:
  1. hernia recurrence [ Time Frame: 1 year ]
    clinical evaluation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals with primary or recurrent incisional hernia were assessed at HUOP, and those with longitudinal or transverse ventral hernia secondary to a previous surgical incision, measuring 5 to 15 cm after dissection of the hernial sac and classified as large or very large according to Chevrel's classification, were considered to be eligible.
  • In individuals with multiple defects, the length between the cranial margin of the most cranial defect and the caudal margin of the most caudal defect was considered

Exclusion Criteria:

  • Individuals subjected to emergency surgery, with infection
  • Immunosuppressed
  • Younger than 18 or older than 80 years old
  • ASA III or IV, with a serum albumin concentration lower than 3.0 g/dl or who refused participation were excluded from the study

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): NCT02163460


Locations
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Brazil
Western Paraná State University / Universidade Estadual do Oeste do Paraná
Cascavel, Paraná, Brazil, 85811-060
Sponsors and Collaborators
Universidade Estadual do Oeste do Paraná
Federal University of São Paulo
Investigators
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Principal Investigator: Andre P Westphalen, MD Universidade Estadual do Oeste do Paraná
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Responsible Party: Universidade Estadual do Oeste do Paraná
ClinicalTrials.gov Identifier: NCT02163460    
Other Study ID Numbers: 009/2011-CEP
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014
Keywords provided by Universidade Estadual do Oeste do Paraná:
ventral hernia
seroma
drainage
infection
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes