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The Efficacy and Security of the Small Stitch Technique in Emergency Surgery

NCT03765060 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-01-13

No results posted yet for this study

Summary

This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique.

Conditions

  • Abdominal Wall Defect
  • Abdominal Wall Hernia
  • Eventration
  • Evisceration; Operation Wound

Interventions

PROCEDURE

Monomax® 2/0 HR26

It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle. In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.

PROCEDURE

Monomax® 1 HR48

It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle. In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Tamayo López María Jesús, PhD · Hospital Universitario Virgen del Rocio

  • Padillo Ruiz Francisco Javier, PhD · Hospital Universitario Virgen del Rocio

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Spain

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 NCT03765060 on ClinicalTrials.gov