Novel method for delayed primary closure and incisional hernia prevention in open abdomen
| ISRCTN | ISRCTN72678033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72678033 |
| Secondary identifying numbers | CEIC 1663 |
- Submission date
- 21/10/2016
- Registration date
- 13/12/2016
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Segrià street 41 2A
Lleida
25006
Spain
 ORCID ID |
0000-0003-0226-2445 |
|---|---|
| Phone | +34 (0)619 080 385 |
| rafovilla26@gmail.com |
Study information
| Study design | Observational prospective study in a single center |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | COMODA method: combined and modified definitive abdominal closure method |
| Study objectives | 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(s) | CEIC (Comité Ético de Investigación Clínica), Clinical Research Ethics Committee, 04/10/2016, ref: CEIC-1663 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 15/01/2015 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Non-trauma critical patient with open abdomen 2. Age range: 18 - 80 |
| Key exclusion criteria | Trauma critical patients with open abdomen |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 30/03/2016 |
Locations
Countries of recruitment
- Spain
Study participating centre
25006
Spain
Sponsor information
Hospital/treatment centre
Alcalde Rovira Roure Avenue 80
Lleida
25198
Spain
| Phone | +34 (0)973 705 298 |
|---|---|
| rvillalobos.lleida@gencat.cat | |
"ROR" |
https://ror.org/01p3tpn79 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | This study will be published in an open access journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 12/12/2016 | 27/01/2017 | No | No | |
| Results article | results | 01/04/2020 | 11/04/2019 | Yes | No |
Additional files
- ISRCTN72678033_BasicResults_12Dec16.docx
- Uploaded 27/01/2017
Editorial Notes
11/04/2019: Publication reference and total final enrolment number added.
27/01/2017: Results summary uploaded.
