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NCT06251583: INDURATE

Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.

Status unknown Phase 3 Last updated 9 February 2024
What this trial tests

Phase 3 trial testing duramesh suture in Incisional Hernia of Anterior Abdominal Wall in 124 participants. Status unknown.

Timeline
22 March 2023
Primary endpoint
22 March 2024
30 June 2025

Quick facts

Lead sponsorMiguel A ngel Garci-a Urena
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment124
Start date22 March 2023
Primary completion22 March 2024
Estimated completion30 June 2025
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Miguel A ngel Garci-a Urena

Who can join

18 and older, any sex, with Incisional Hernia of Anterior Abdominal Wall or Dehiscence Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias. INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06251583.

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