Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03765060
Other study ID # SL-Stitch
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2021

Study information

Verified date December 2020
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Tamayo López María Jesús, PhD
Phone 686589986
Email mtamayolopez@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients over 18 years of age and who provide informed consent to participate in the study. 2. Patients requiring an urgent midline laparotomy with a minimum size of 8 cm. Exclusion Criteria: 1. Prior midline laparotomy. 2. Patients with BMI> 45 kg / m2 3. Patients with ASA (American Society of Anesthesiologists)> IV. 4. Patient with an advanced terminal illness with an expectation of life <1 year. 5. Patients with abdominal aortic aneurysm. 6. Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura. 7. Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment. 8. Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma. 9. Chemotherapeutic treatment 2 weeks before surgery. 10. Radiotherapy treatment 6 weeks before surgery. 11. Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process. 12. Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant, or those who do not wish to use effective contraception (hormonal contraceptives (implantation, patches, oral), and double barrier methods (any double combination of: IUD (intrauterine device), male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).

Study Design


Intervention

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.
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.

Locations

Country Name City State
Spain Hospital Universitario Virgen Del Rocio Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. — View Citation

Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11. Review. — View Citation

Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30. — View Citation

Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10. — View Citation

O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of the small stitch technique defined by eventration rate To determine the efficacy of the "Small stitch" technique versus the "Large Stitch" technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery. 1 year
Secondary Efficacy of the small stitch technique defined by local complications rate To determine whether the closure of midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection. 1 year
Secondary Efficacy of the small stitch technique defined by evisceration rate To determine if the closure of the midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration. 1 year
Secondary Efficacy of the small stitch technique defined by improvement of quality of life To determine if the closure of a midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery improves the quality of life. 1 year
Secondary Security of the small stitch technique To determine the safety of the Small Stitch technique versus the "Large Stitch" technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study. 1 year
See also
  Status Clinical Trial Phase
Completed NCT04644965 - Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect
Recruiting NCT06086444 - Tranexamic Acid in Abdominoplasty. Phase 4
Completed NCT05579652 - Change in Fascial Tension in Open Abdomens
Terminated NCT03241719 - Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA Early Phase 1
Recruiting NCT04580511 - Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
Recruiting NCT03035617 - Study to Evaluate Reduction in Pain After Laparoscopic Hernia Repair With Mesh Soaked in Bupivacaine Solution N/A
Not yet recruiting NCT06367309 - ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair N/A
Completed NCT05061264 - Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection N/A
Recruiting NCT03310905 - Abdominal Wall Transplant N/A
Completed NCT03960320 - Health Related Quality of Life of Patients With Abdominal Wall Defects
Recruiting NCT05308771 - To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery N/A
Recruiting NCT02416674 - Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects Early Phase 1
Not yet recruiting NCT06364306 - oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias N/A
Completed NCT05278117 - A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step N/A
Completed NCT04947202 - Clinical Study on the Safety of SAFIL® MESH
Enrolling by invitation NCT03296475 - Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction N/A
Completed NCT03702153 - The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial N/A
Completed NCT05205213 - Stepwise for the Treatment of Lateral Incisional Hernias