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Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

Primary Purpose

Surgical Wound Dehiscence

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

prophylactic polypropilene mesh

Midline Fascial Closure

vacuum drainage system

About this trial

This is an interventional prevention trial for Surgical Wound Dehiscence focused on measuring laparotomy, emergency surgery, abdominal wound dehiscence, prophylactic mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Suture group

Prophylactic mesh group

Arm Description

Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure.

Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.

Outcomes

Primary Outcome Measures

Fascial dehiscence incidence

Secondary Outcome Measures

Surgical site occurence (SSO) incidence

Surgical site occurrence requiring procedural intervention (SSOPI) incidence

Operative time (minutes),

Hospital length of stay (days)

Intensive care unit length of stay (days)

Full Information

NCT ID

NCT03293862

First Posted

September 20, 2017

Last Updated

April 15, 2019

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03293862

Brief Title

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Wound Dehiscence

Keywords

laparotomy, emergency surgery, abdominal wound dehiscence, prophylactic mesh

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Suture group and prophylactic mesh group

Masking

Care Provider

Allocation

Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suture group

Arm Type

Active Comparator

Arm Description

Arm Title

Prophylactic mesh group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

prophylactic polypropilene mesh

Intervention Description

Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

Intervention Type

Procedure

Intervention Name(s)

Midline Fascial Closure

Intervention Description

midline fascial closure using uninterrupted PDS 0 suture

Intervention Type

Device

Intervention Name(s)

vacuum drainage system

Intervention Description

Placement of a subcutaneous vacuum drainage system

Primary Outcome Measure Information:

Title

Fascial dehiscence incidence

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Surgical site occurence (SSO) incidence

Time Frame

30 days or during hospital stay

Title

Surgical site occurrence requiring procedural intervention (SSOPI) incidence

Time Frame

30 days or during hospital stay

Title

Operative time (minutes),

Time Frame

30 days

Title

Hospital length of stay (days)

Time Frame

30 days

Title

Intensive care unit length of stay (days)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

City

São Paulo

State/Province

São

ZIP/Postal Code

05403000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23648044

Citation

Gomez Diaz CJ, Rebasa Cladera P, Navarro Soto S, Hidalgo Rosas JM, Luna Aufroy A, Montmany Vioque S, Corredera Cantarin 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.

Results Reference

background

PubMed Identifier

19898894

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.

Results Reference

result

PubMed Identifier

31672681

Citation

Lima HVG, Rasslan R, Novo FCF, Lima TMA, Damous SHB, Bernini CO, Montero EFS, Utiyama EM. Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Jan;230(1):76-87. doi: 10.1016/j.jamcollsurg.2019.09.010. Epub 2019 Oct 28.

Results Reference

derived

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Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

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