Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

Surgical Wound Dehiscence Clinical Trial

Official title:

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293862
• Other study ID #: 2024878
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Facial dehiscence elicit high morbidity and mortality. This complication may arise in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on the incidence of fascial dehiscence in emergency surgery and associated complications.

Description:

Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more than 8.5% of high-risk patients. Current preventive measures described are control of risk factors and optimization of surgical technique. Despite that, the incidence of such complication remained stable in the last decades, highlighting the low efficacy of such measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected elective patients, and could be useful in the prevention of fascial dehiscence. In emergency situations, especially in contaminated and infected surgical procedures, safety and efficacy of mesh is controversial. In this study the investigators aimed to evaluate the influence of polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk patients undergoing midline emergency laparotomy. As secondary outcome, the associated morbidity, including surgical site occurence, will be analyzed. The study design will be a randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency laparotomy by midline incision

• High risk for abdominal wound dehiscence: Risk index** = 4,0 or = 2,2 in combination with at least one of the following: smoking, obesity, malnutrition or malignant neoplasia.

• Risk index is the sum of values associated with high-risk characteristics, based in the risk score for abdominal wall dehiscence published by van Ramshorst et. al. in World Journal of Surgery, 2010 (Rotterdam risk model):

Age category (in years)

• 40-49: 0.4

• 50-59: 0.9

• 60-69: 0.9

• =70: 1.1

Male gender: 0.7

Chronic pulmonary disease: 0.7

Ascites: 1.5

Jaundice: 0.5

Anemia: 0.7

Emergency surgery: 0.6

Type of surgery:

• Gallbladder/bile duct 0.7

• Esophagus 1.5

• Gastroduodenum 1.4

• Small bowel 0.9

• Large bowel 1.4

• Vascular 1.3

Exclusion Criteria:

• Non-midline incisions or midline laparotomy measuring less than 1/4 the distance between the xyphoid and the pubis, including laparoscopic surgery.

• Diagnosis of incisional hernia or presence of previous mesh on site.

• Midline laparotomy performed in less than 30 days.

• Pregnancy

• Severe trauma with hemodynamic instability

• Need for open abdomen or relaxing incisions

• Need for re-laparotomy during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed.

• Death during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed before the event.

Related Conditions & MeSH terms

• Emergencies
• Surgical Wound
• Surgical Wound Dehiscence

Intervention

Device:
• prophylactic polypropilene mesh
Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

Procedure:
• Midline Fascial Closure
midline fascial closure using uninterrupted PDS 0 suture

Device:
• vacuum drainage system
Placement of a subcutaneous vacuum drainage system

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	São

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Gómez Díaz CJ, Rebasa Cladera P, Navarro Soto S, Hidalgo Rosas JM, Luna Aufroy A, Montmany Vioque S, Corredera Cantarín C. [Validation of abdominal wound dehiscence's risk model]. Cir Esp. 2014 Feb;92(2):114-9. doi: 10.1016/j.ciresp.2012.12.008. Epub 2013 May 3. Spanish. — View Citation

van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fascial dehiscence incidence		30 days
Secondary	Surgical site occurence (SSO) incidence		30 days or during hospital stay
Secondary	Surgical site occurrence requiring procedural intervention (SSOPI) incidence		30 days or during hospital stay
Secondary	Operative time (minutes),		30 days
Secondary	Hospital length of stay (days)		30 days
Secondary	Intensive care unit length of stay (days)		30 days