Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT03765060
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2018-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Security of the Small Stitch Technique in Emergency Surgery
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
Official Title:
Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STCU
Brief 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.
Detailed Description:
The closure of laparotomy is one of the most important challenges facing the surgeon.
The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm.
Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches.
There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.
The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm.
Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches.
There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: