Condition category
Surgery
Date applied
21/10/2016
Date assigned
13/12/2016
Last edited
27/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The term open abdomen refers to when an incision (cut) in the abdomen is intentionally left open at the end of surgery. It is a treatment option for cases of trauma (injury) but also for non-trauma patients, especially for those with severe sepsis (blood poisoning). Various techniques of temporary abdominal closure have been developed in order to achieve closure with few complications such as incisional hernia. The aim of this study is to test whether a new method called COmbined and MOdified Definitive Abdominal closure (COMODA), which involves applying low pressure combined with a fixed mesh, increases the rate of closure and reduces the risk of developing an incisional hernia.

Who can participate?
Patients aged 18 - 80 with an open abdomen that is not due to trauma

What does the study involve?
The patients’ wounds are examined every 3-4 days or on demand to measure the rate of closure. The incidence of incisional hernia is measured by CT scan after 6 months.

What are the possible benefits and risks of participating?
The treatment may increase the rate of closure and decrease the risk of developing an incisional hernia. There are risks of surgical complications (bowel adhesions, enteroatmospheric fistulae).

Where is the study run from?
Arnau de Vilanova University Hospital (Spain)

When is the study starting and how long is it expected to run for?
January 2015 to June 2016

Who is funding the study?
1. B. Braun Surgical
2. Smith & Nephew

Who is the main contact?
Dr Rafael Villalobos
rafovilla26@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rafael Villalobos

ORCID ID

http://orcid.org/0000-0003-0226-2445

Contact details

Segrià street 41 2A
Lleida
25006
Spain
+34 (0)619 080 385
rafovilla26@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CEIC 1663

Study information

Scientific title

COMODA method: combined and modified definitive abdominal closure method

Acronym

Study hypothesis

Open abdomen management has become a therapeutic option for not only cases of trauma but also for non-trauma patients, especially for those with severe sepsis. It is nonetheless associated with high rates of morbidity and mortality. Various techniques of temporary abdominal closure have been developed in order to improve the management and to achieve delayed primary closure with minimal complications, either early or late (incisional hernia). A novel method called COmbined and MOdified Definitive Abdominal closure (COMODA) has been developed for obtaining a delayed open abdomen primary closure with a lower risk for subsequently developing an incisional hernia.

This observational study is taking place to find out whether use of COMODA can improve abdominal wall closure in open abdomen and avoid a posterior incisional hernia.

Ethics approval

CEIC (Comité Ético de Investigación Clínica), Clinical Research Ethics Committee, 04/10/2016, ref: CEIC-1663

Study design

Observational prospective study in a single center

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Critical non-trauma patient with an open abdomen

Intervention

Prospective observational study in which a negative pressure wound therapy (NPWT) system is combined with a condensed polytetrafluoroethylene (cPTFE) mesh fixed 5 cm from the aponeurotic edges. Demographic variables, comorbidities, intra-abdominal pressure measurements, number of surgeries, time until definitive closure, early and late complications were studied. This method was used in non-trauma patients, mainly with sepsis, with the wound being examined every 3-4 days or on demand, with constant medial traction applied to the edges. When primary closure was achieved, the remaining cPTFE mesh served as intraperitoneal reinforcement. The treatment is a new technique for abdominal wall closure in open abdomen that the authors hope will allow closure in 2 - 3 weeks. Follow-up after closure: 6 months.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Rate of definitive abdominal wall closure, determined by wound examination every 3-4 days until closure

Secondary outcome measures

Incidence of incisional hernias, determined with abdominal computerized tomography after 6 months

Overall trial start date

15/01/2015

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-trauma critical patient with open abdomen
2. Age range: 18 - 80

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Trauma critical patients with open abdomen

Recruitment start date

01/02/2015

Recruitment end date

30/03/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Arnau de Vilanova University Hospital
Lleida
25006
Spain

Sponsor information

Organisation

Arnau de Vilanova University Hospital

Sponsor details

Alcalde Rovira Roure Avenue 80
Lleida
25198
Spain
+34 (0)973 705 298
rvillalobos.lleida@gencat.cat

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

B. Braun Surgical

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Smith & Nephew

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study will be published in an open access journal.

IPD sharing plans
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2017

Participant level data

To be made available at a later date

Results - basic reporting

See additional file ISRCTN72678033_BasicResults_12Dec16.docx

Publication summary

Publication citations

Additional files

Editorial Notes

27/01/2017: Results summary uploaded.