A Phase 3 interventional study of duramesh suture in Incisional Hernia of Anterior Abdominal Wall, Dehiscence Wound and Wound Infection, sponsored by Miguel A ngel Garci-a Urena. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Miguel A ngel Garci-a Urena · Phase 3, Interventional, and Prevention
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.
270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.
This study's planned enrollment of 124 is below the median of 141 across 228 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →This is the only study on the registry with Miguel A ngel Garci-a Urena as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Umbilical trocar closure using Suture-mesh (Duramesh suture).
Device: duramesh suture
Umbilical trocar closure using conventional monofilament suture.
Device: duramesh suture
Duramesh-suture will be used for trocar closure in the experimental group
Incidence of the umbilical trocar site hernia in each group
Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group
Time frame: 12 monts
Infectious complications of the wound
Evaluation of the infectious complications related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
Time frame: 12 months
Seroma and hematoma
Evaluation of the seroma and hematoma related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
Time frame: 12 months
Intraabdominal events
Evaluation of intraabdominal events (fluid collections, bleeding, peritonitis...) and compare the incidence in each group.
Time frame: 12 months
Skin dehiscence and/or necrosis
Evaluate the incidence of skin complications in each group.
Time frame: 12 months
Early aponeurotic failure (evisceration)
Evaluation of early aponeurotic failure after laparoscopic procuderes and compare the incidence between the two different groups.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Mar 2024, 12 months after the start.
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