Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used

NCT06501508 | Unknown FDA Device

• 1 other identifier: PIC089-23_FJD
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 4

Brief Summary

In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision, comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall. In addition, we plan to analize the impact of other risk factors, patient related and patient unrelated, on the incidence of fascial dehiscence.

Conditions

Surgical Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

• Abdominal Wall Dehiscence

  Disruption of all layers of the abdominal wall with exposure of abdominal viscera within 30 days after primary surgery

  30 days

Secondary Outcomes (8)

• Incisional hernia

  1 year

• PROMs - Postoperative Pain

  1 year

• PROMs - Mental and emotional health

  1 year

• PROMs - Work an social life performance

  1 year

• PROMs - Fatigue

  1 year

Study Arms (2)

Stratafix

All patients in which Stratafix symmetric was used for the primary closure of the abdominal wall incision

Device: Stratafix Symmetric

Control

All patients in which other, conventional suture types were used for primary closure of the abdominal wall incision

Interventions

Stratafix Symmetric DEVICE

Use of Stratafix Symmetric for primary fascial closure

Stratafix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults over 18 years of age operated via laparotomy or laparoscopy with extraction site incision in the 4 participating Hospitals between 01/01/2018 and 21/11/23

You may qualify if:

• Age over 18 years, abdominal incision or laparoscopy with extraction site incision

You may not qualify if:

• Pregnancy, use of mesh for fascial closure in primary surgery, history of ventral abdominal hernia surgery

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Ethicon, Inc.: collaborator

Study Sites (4)

Hospital universitario General de Villalba

Collado Villalba, Madrid, 28400, Spain

RECRUITING

Hospital Universitario Infanta Elena

Valdemoro, Madrid, 28342, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Rey Juan Carlos

Madrid, 28933, Spain

RECRUITING

Related Publications (15)

• Zolin SJ, Rosen MJ. Failure of Abdominal Wall Closure: Prevention and Management. Surg Clin North Am. 2021 Oct;101(5):875-888. doi: 10.1016/j.suc.2021.07.001.

  PMID: 34537149 BACKGROUND

• Rodriguez-Hermosa JI, Codina-Cazador A, Ruiz B, Roig J, Girones J, Pujadas M, Pont J, Aldeguer X, Acero D. [Risk factors for acute abdominal wall dehiscence after laparotomy in adults]. Cir Esp. 2005 May;77(5):280-6. doi: 10.1016/s0009-739x(05)70854-x. Spanish.

  PMID: 16420934 BACKGROUND

• Gili-Ortiz E, Gonzalez-Guerrero R, Bejar-Prado L, Ramirez-Ramirez G, Lopez-Mendez J. [Postoperative dehiscence of the abdominal wound and its impact on excess mortality, hospital stay and costs]. Cir Esp. 2015 Aug-Sep;93(7):444-9. doi: 10.1016/j.ciresp.2015.02.005. Epub 2015 May 6. Spanish.

  PMID: 25956459 BACKGROUND

• Jensen KK, Oma E, van Ramshorst GH, Nordholm-Carstensen A, Krarup PM. Abdominal wound dehiscence is dangerous: a nationwide study of 14,169 patients undergoing elective open resection for colonic cancer. Hernia. 2022 Feb;26(1):75-86. doi: 10.1007/s10029-020-02350-z. Epub 2021 Jan 4.

  PMID: 33394254 BACKGROUND

• Farquhar M. AHRQ Quality Indicators. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 45. Available from http://www.ncbi.nlm.nih.gov/books/NBK2664/

  PMID: 21328764 BACKGROUND

• Zucker BE, Simillis C, Tekkis P, Kontovounisios C. Suture choice to reduce occurrence of surgical site infection, hernia, wound dehiscence and sinus/fistula: a network meta-analysis. Ann R Coll Surg Engl. 2019 Mar;101(3):150-161. doi: 10.1308/rcsann.2018.0170. Epub 2018 Oct 5.

  PMID: 30286645 BACKGROUND

• Jenkins TP. The burst abdominal wound: a mechanical approach. Br J Surg. 1976 Nov;63(11):873-6. doi: 10.1002/bjs.1800631110.

  PMID: 137024 BACKGROUND

• Henriksen NA, Deerenberg EB, Venclauskas L, Fortelny RH, Miserez M, Muysoms FE. Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review. World J Surg. 2018 Jun;42(6):1666-1678. doi: 10.1007/s00268-017-4393-9.

  PMID: 29322212 BACKGROUND

• Patel SV, Paskar DD, Nelson RL, Vedula SS, Steele SR. Closure methods for laparotomy incisions for preventing incisional hernias and other wound complications. Cochrane Database Syst Rev. 2017 Nov 3;11(11):CD005661. doi: 10.1002/14651858.CD005661.pub2.

  PMID: 29099149 BACKGROUND

• Cengiz Y, Blomquist P, Israelsson LA. Small tissue bites and wound strength: an experimental study. Arch Surg. 2001 Mar;136(3):272-5. doi: 10.1001/archsurg.136.3.272.

  PMID: 11231844 BACKGROUND

• Fortelny RH. Abdominal Wall Closure in Elective Midline Laparotomy: The Current Recommendations. Front Surg. 2018 May 23;5:34. doi: 10.3389/fsurg.2018.00034. eCollection 2018.

  PMID: 29876355 BACKGROUND

• Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25.

  PMID: 25618025 BACKGROUND

• Tolstrup MB, Watt SK, Gogenur I. Reduced Rate of Dehiscence After Implementation of a Standardized Fascial Closure Technique in Patients Undergoing Emergency Laparotomy. Ann Surg. 2017 Apr;265(4):821-826. doi: 10.1097/SLA.0000000000001762.

  PMID: 28267697 BACKGROUND

• Denys A, Monbailliu T, Allaeys M, Berrevoet F, van Ramshorst GH. Management of abdominal wound dehiscence: update of the literature and meta-analysis. Hernia. 2021 Apr;25(2):449-462. doi: 10.1007/s10029-020-02294-4. Epub 2020 Sep 8.

  PMID: 32897452 BACKGROUND

• Pereira Rodriguez JA, Amador-Gil S, Bravo-Salva A, Montcusi-Ventura B, Sancho-Insenser JJ, Pera-Roman M, Lopez-Cano M. Small bites technique for midline laparotomy closure: From theory to practice: Still a long way to go. Surgery. 2021 Jul;170(1):140-145. doi: 10.1016/j.surg.2020.12.007. Epub 2021 Jan 15.

  PMID: 33455821 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hector Gauadalajara Labajo, PHD

  Quironsalud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hector Gauadalajara Labajo, PHD

CONTACT

0034649429243; h.guadalajara@quironsalud.es

Marius Kaser, Dr.

CONTACT

0034652174951

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: July 15, 2024
• Study Start: November 22, 2023
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: July 15, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)