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Surgical Wound DehiscenceNCT03293862

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

A study testing prophylactic polypropilene mesh, Midline Fascial Closure and vacuum drainage system in people with Surgical Wound Dehiscence, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Wound Dehiscence
What is being tested?
prophylactic polypropilene mesh, Midline Fascial Closure and vacuum drainage system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteBrazil
Study dates
Jun 2015to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    São Paulo, São, 05403000

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
prophylactic polypropilene mesh, Midline Fascial Closure, vacuum drainage system
Keywords
laparotomy, emergency surgery, abdominal wound dehiscence, prophylactic mesh
Medical subject headings
Surgical Wound Dehiscence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prophylactic polypropilene meshDevice

    Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

  • Midline Fascial ClosureProcedure or surgery

    midline fascial closure using uninterrupted PDS 0 suture

  • vacuum drainage systemDevice

    Placement of a subcutaneous vacuum drainage system

Study groups in NCT03293862
Study groupRoleWhat they receive
Suture groupActive comparatorPatients 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.
Receives: Procedure: Midline Fascial Closure
Prophylactic mesh groupExperimentalPatients 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.
Receives: Device: prophylactic polypropilene mesh; Procedure: Midline Fascial Closure; Device: vacuum drainage system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fascial dehiscence incidence

    Measured: 30 days

Secondary outcomes (5)

  1. Surgical site occurence (SSO) incidence

    Measured: 30 days or during hospital stay

  2. Surgical site occurrence requiring procedural intervention (SSOPI) incidence

    Measured: 30 days or during hospital stay

  3. Operative time (minutes),

    Measured: 30 days

  4. Hospital length of stay (days)

    Measured: 30 days

  5. Intensive care unit length of stay (days)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study startJun 2015
  3. Primary completionMar 2017
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Suture group and prophylactic mesh group
Masking
Single blind
Who is masked
Care provider
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03293862
Sponsor's protocol ID
2024878
Status last verified
Apr 2019
First submitted
20 Sep 2017
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23648044

  • 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.

    PubMed 19898894

  • 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.

    PubMed 31672681

Questions about this trial

What is this clinical trial studying?

A study testing prophylactic polypropilene mesh, Midline Fascial Closure and vacuum drainage system in people with Surgical Wound Dehiscence, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fascial dehiscence incidence (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03293862, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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