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 measure
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 (if study stopped)
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
Basic results (scientific)
See additional file ISRCTN72678033_BasicResults_12Dec16.docx
Publication list
Publication citations
Additional files
- ISRCTN72678033_BasicResults_12Dec16.docx Uploaded 27/01/2017