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

NCT02163460 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-06-13

No results posted yet for this study

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.

Conditions

  • Ventral Hernia

Interventions

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.

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

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER

  • Universidade Estadual do Oeste do Paraná

    lead OTHER

Principal Investigators

  • Andre P Westphalen, MD · Universidade Estadual do Oeste do Paraná

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-01-31
Completion
2014-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02163460 on ClinicalTrials.gov