Last reviewed · How we verify
NCT06251583: INDURATE
Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.
Phase 3 trial testing duramesh suture in Incisional Hernia of Anterior Abdominal Wall in 124 participants. Status unknown.
22 March 2024
Quick facts
| Lead sponsor | Miguel A ngel Garci-a Urena |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 124 |
| Start date | 22 March 2023 |
| Primary completion | 22 March 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- duramesh suture
Conditions studied
- Incisional Hernia of Anterior Abdominal Wall — all drugs for Incisional Hernia of Anterior Abdominal Wall →
- Dehiscence Wound — all drugs for Dehiscence Wound →
- Wound Infection — all drugs for Wound Infection →
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.
Verify or expand the search:
- PubMed search for NCT06251583
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06251583 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Miguel A ngel Garci-a Urena
- Last refreshed: 9 February 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing