Fascial Abdominal Closure Evaluation | NCT07683546

Studies
Fascial Abdominal Closure Evaluation

NCT07683546

Sponsor

Aristotle University Of Thessaloniki

Status

Not yet recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Hernia Incisional
Suture Materials
Duramesh

Interventions

DURAMESH
(Ethicon) PDS II 1-0 double loop

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Mar 31, 2029Estimated

Completion Date

Mar 31, 2029Estimated

First Submitted Date

Jun 25, 2026

First Submission Date that Met QC Criteria

Jul 1, 2026

First Posted Date

Jul 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dimitrios Zouzoulas, Gynecological Oncologist, MSc, PhD, FEBS-BS, FESGO-EBCOG, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARM A: Control Arm	Active Comparator	(Ethicon) PDS II 1-0 double loop suture material with a 48mm needle	Device: (Ethicon) PDS II 1-0 double loop
ARM B: Intervention Arm	Experimental	Duramesh suture with a 48mm needle	Device: DURAMESH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DURAMESH	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of incisional hernia	Clinical or radiological detected	Up to 12 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
Incidence of wound dehiscence		Up to 1 month after randomization
Incidence of wound infection		Up to 1 months after randomization
Visual Analogue Scale (VAS) for wound pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Midline laparotomies for gynecological malignancies
Age 18 - 85 years old
ECOG Performance status: 0 - 2

Exclusion Criteria:

Pregnancy
Albumin < 3.5 g/dL
Previous history of any type of hernia
Previous midline incision (via laparotomy)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dimitrios Zouzoulas, MD, MSc, PhD	Contact	+306946536065		dzouzoulas@hotmail.gr

Overall Officials

Name	Affiliation	Role
Dimitrios Tsolakidis, Dr. Prof.	Aristotle University Of Thessaloniki	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Sharing of IPD only after contact with the principal investigator for the synthesis of future studies

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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).