Hernia IncisionalFACENCT07683546
Fascial Abdominal Closure Evaluation
A study testing DURAMESH and (Ethicon) PDS II 1-0 double loop in people with Hernia Incisional and Suture Materials, run by Aristotle University Of Thessaloniki.
Trial summary
FACE (Fascial Abdominal Closure Evaluation) Trial is a prospective, single center, open-label, randomized trial of Duramesh versus PDS loop suture for midline incision fascial abdominal closure evaluation in patients with gynecological malignancies Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hernia Incisional, Suture Materials, Duramesh
- What is being tested?
- DURAMESH and (Ethicon) PDS II 1-0 double loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Mar 2029
- 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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Midline laparotomies for gynecological malignancies
- Age 18 - 85 years old
- ECOG Performance status: 0 - 2
Who cannot join
- Pregnancy
- Albumin < 3.5 g/dL
- Previous history of any type of hernia
- Previous midline incision (via laparotomy)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies
FACE (Fascial Abdominal Closure Evaluation) Trial is a prospective, single center, open-label, randomized trial of Duramesh versus PDS loop suture for midline incision fascial abdominal closure evaluation in patients with gynecological malignancies
Read the detailed description
Incisional hernias after midline incisions are estimated are estimated around 10-20%, which many times results in further surgical procedures. Many techniques with different sutures have been proposed of the years for fascial closure. PDS suture offers longer dissolution time, lower short-term tensile strength and lower knot security, however the highest quality data available for gynecological malignancies are from 30 years ago. On the other hand, the use of mesh suture (Duramesh) has been proposed as an alternative, in order to reduce postoperative hernias and abdominal wall complication rates. A recent systematic review on Duramesh shows promising results with a median incisional hernia occurrence of 3.4%, but the authors highlight the need for high-quality randomized controlled trials with long-term follow-up to evaluate the clinical benefits of Duramesh.
- Conditions
- Hernia Incisional, Suture Materials, Duramesh
- Being tested
- DURAMESH, (Ethicon) PDS II 1-0 double loop
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DURAMESHDevice
Duramesh is a non-absorbable polypropylene "mesh suture": a suture that is built like a tiny mesh tube so it behaves both as a suture and as a small piece of mesh to strengthen tissue closure
(Ethicon) PDS II 1-0 double loopDevice
(Ethicon) PDS II 1-0 double loop suture with a 48 mm needle is a slowly absorbable, synthetic monofilament polydioxanone suture designed to provide prolonged tensile support for fascial and other soft-tissue closure where extended wound support is desired
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Control Arm | Active comparator | (Ethicon) PDS II 1-0 double loop suture material with a 48mm needle Receives: Device: (Ethicon) PDS II 1-0 double loop |
| ARM B: Intervention Arm | Experimental | Duramesh suture with a 48mm needle Receives: Device: DURAMESH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia
Clinical or radiological detected
Measured: Up to 12 months after randomization
Secondary outcomes (3)
Incidence of wound dehiscence
Measured: Up to 1 month after randomization
Incidence of wound infection
Measured: Up to 1 months after randomization
Visual Analogue Scale (VAS) for wound pain
Wound pain will be assessed with the Visual Analogue Scale (VAS). The minimum value is 0 (no pain) and the maximum value is 10 (Pain as bad as it could possibly be). The VAS line is 10cm long. Higher scores mean a worse outcome.
Measured: Fifth postoperative day after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia IncisionalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * ARM A: Control Arm: Continuous technique fascial closure with small bite widths of 0,5cm and inter suture spacing of 0,5cm with the use of (Ethicon) PDS II 1-0 double loop suture material with a 48mm needle. If the incision's length is over 20cm, 2 sutures will be used (starting from top and bottom, respectively). * ARM B: Intervention Arm: Continuous technique fascial closure with small bite widths of 0,5cm and inter suture spacing of 0,5cm with the use of Duramesh\* with a 48mm needle. If the incision's length is over 20cm, 2 sutures will be used (starting from top and bottom, respectively).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Zouzoulas, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios Tsolakidis, Dr. Prof., Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683546
- Sponsor's protocol ID
- 2026- Β230-AN-564
- Acronym
- FACE
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD only after contact with the principal investigator for the synthesis of future studies
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT07683546
- Acronym / sponsor ID
- FACE / 2026- Β230-AN-564
- Conditions
- Hernia Incisional, Suture Materials, Duramesh
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Jul 2026 (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.
FACE (Fascial Abdominal Closure Evaluation) Trial is a prospective, single center, open-label, randomized trial of Duramesh versus PDS loop suture for midline incision fascial abdominal closure evaluation in patients with gynecological malignancies
Detailed description
Incisional hernias after midline incisions are estimated are estimated around 10-20%, which many times results in further surgical procedures. Many techniques with different sutures have been proposed of the years for fascial closure. PDS suture offers longer dissolution time, lower short-term tensile strength and lower knot security, however the highest quality data available for gynecological malignancies are from 30 years ago. On the other hand, the use of mesh suture (Duramesh) has been proposed as an alternative, in order to reduce postoperative hernias and abdominal wall complication rates. A recent systematic review on Duramesh shows promising results with a median incisional hernia occurrence of 3.4%, but the authors highlight the need for high-quality randomized controlled trials with long-term follow-up to evaluate the clinical benefits of Duramesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * ARM A: Control Arm: Continuous technique fascial closure with small bite widths of 0,5cm and inter suture spacing of 0,5cm with the use of (Ethicon) PDS II 1-0 double loop suture material with a 48mm needle. If the incision's length is over 20cm, 2 sutures will be used (starting from top and bottom, respectively). * ARM B: Intervention Arm: Continuous technique fascial closure with small bite widths of 0,5cm and inter suture spacing of 0,5cm with the use of Duramesh* with a 48mm needle. If the incision's length is over 20cm, 2 sutures will be used (starting from top and bottom, respectively).
| Arm | Type | Receives |
|---|---|---|
| ARM A: Control Arm | Active comparator | Device: (Ethicon) PDS II 1-0 double loop(Ethicon) PDS II 1-0 double loop suture material with a 48mm needle |
| ARM B: Intervention Arm | Experimental | Device: DURAMESHDuramesh suture with a 48mm needle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Midline laparotomies for gynecological malignancies
- Age 18 - 85 years old
- ECOG Performance status: 0 - 2
Key exclusion criteria (4 listed)
- Pregnancy
- Albumin < 3.5 g/dL
- Previous history of any type of hernia
- Previous midline incision (via laparotomy)
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 |
|---|---|---|
| DURAMESHDuramesh is a non-absorbable polypropylene "mesh suture": a suture that is built like a tiny mesh tube so it behaves both as a suture and as a small piece of mesh to strengthen tissue closure | Device | ARM B: Intervention Arm |
| (Ethicon) PDS II 1-0 double loop(Ethicon) PDS II 1-0 double loop suture with a 48 mm needle is a slowly absorbable, synthetic monofilament polydioxanone suture designed to provide prolonged tensile support for fascial and other soft-tissue closure where extended wound support is desired | Device | ARM A: Control Arm |
Primary outcome
Incidence of incisional hernia
Time frame: Up to 12 months after randomization
Clinical or radiological detected
3 secondary outcomes
Incidence of wound dehiscence
Time frame: Up to 1 month after randomization
Incidence of wound infection
Time frame: Up to 1 months after randomization
Visual Analogue Scale (VAS) for wound pain
Time frame: Fifth postoperative day after randomization
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 6 Jul 2026.
- Individual participant dataSharing planned: No. Sharing of IPD only after contact with the principal investigator for the synthesis of future studies
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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.
Dimitrios Tsolakidis, Dr. Prof. principal investigator
Aristotle University Of Thessaloniki
Questions about this trial
What is this clinical trial studying?
A study testing DURAMESH and (Ethicon) PDS II 1-0 double loop in people with Hernia Incisional and Suture Materials, run by Aristotle University Of Thessaloniki.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dimitrios Zouzoulas, MD, MSc, PhD (+306946536065, dzouzoulas@hotmail.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernia (time frame: Up to 12 months after randomization). 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 6 Jul 2026.