Incisional Hernia After Midline LaparotomyONCOSTRATNCT07218679
Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
A study testing Stratafix Suture and PDS plus suture in people with Incisional Hernia After Midline Laparotomy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to the use of a monofilament suture following the Small Stitch technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia After Midline Laparotomy
- What is being tested?
- Stratafix Suture and PDS plus suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 21 May 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age who will undergo midline laparotomy for oncologic resection of a retroperitoneal tumor or cytoreductive surgery for carcinomatosis of any origin.
Who cannot join
- Diagnosed incisional hernia.
- When the planned midline laparotomy is expected to be less than 20 cm.
- Patients with a BMI > 45 kg/m².
- Patients with abdominal aortic aneurysm.
- Patients with coagulopathy: previously diagnosed with von Willebrand disease, hemophilia, or idiopathic thrombocytopenic purpura.
- Patients with collagen disorders: previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria, or scleroderma.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to the use of a monofilament suture following the Small Stitch technique.
- Being tested
- Stratafix Suture, PDS plus suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratafix SutureDevice
Midline laparotomy closure using Stratafix vs PDS plus.
PDS plus sutureDevice
Midline laparotomy closure using PDS plus.
| Study group | Role | What they receive |
|---|---|---|
| Stratafix | Experimental | Midline laparotomy closure with Stratafix suture. Receives: Device: Stratafix Suture |
| PDS plus | Active comparator | Midline laparotomy closure with PDS plus suture Receives: Device: PDS plus suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia
Incisional hernia rate after midline laparotomy closure.
Measured: 12 months
Secondary outcomes (4)
Wound infection
Compare the wound infection rate after midline laparotomy closure with Stratafix vs PDS plus.
Measured: 12 months.
Wound seroma
Compare the wound seroma rate after midline laparotomy closure with Stratafix vs PDS plus.
Measured: 12 months
Hematoma
Compare the hematoma rate after midline laparotomy closure with Stratafix vs PDS plus.
Measured: 12 months
Evisceration
Compare the evisceration rate after midline laparotomy closure with Stratafix vs PDS plus.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start21 May 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia After Midline LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218679
- Sponsor's protocol ID
- FIS-STRA-2024-01
- Acronym
- ONCOSTRAT
- Status last verified
- Jul 2025
- First submitted
- 16 Oct 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
- ClinicalTrials.gov ID
- NCT07218679
- Acronym / sponsor ID
- ONCOSTRAT / FIS-STRA-2024-01
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to the use of a monofilament suture following the Small Stitch technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratafix | Experimental | Device: Stratafix SutureMidline laparotomy closure with Stratafix suture. |
| PDS plus | Active comparator | Device: PDS plus sutureMidline laparotomy closure with PDS plus suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age who will undergo midline laparotomy for oncologic resection of a retroperitoneal tumor or cytoreductive surgery for carcinomatosis of any origin.
Key exclusion criteria (6 listed)
- Diagnosed incisional hernia.
- When the planned midline laparotomy is expected to be less than 20 cm.
- Patients with a BMI > 45 kg/m².
- Patients with abdominal aortic aneurysm.
- Patients with coagulopathy: previously diagnosed with von Willebrand disease, hemophilia, or idiopathic thrombocytopenic purpura.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stratafix SutureMidline laparotomy closure using Stratafix vs PDS plus. | Device | Stratafix |
| PDS plus sutureMidline laparotomy closure using PDS plus. | Device | PDS plus |
Primary outcome
Incisional hernia
Time frame: 12 months
Incisional hernia rate after midline laparotomy closure.
4 secondary outcomes
Wound infection
Time frame: 12 months.
Wound seroma
Time frame: 12 months
Hematoma
Time frame: 12 months
Evisceration
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratafix Suture and PDS plus suture in people with Incisional Hernia After Midline Laparotomy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incisional hernia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2025.