Fascial Abdominal Closure Evaluation (FACE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hernia Incisional; Suture Materials; Duramesh
• Intervention / Treatment: Device: (Ethicon) PDS II 1-0 double loop; Device: DURAMESH

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimitrios Zouzoulas, MD, MSc, PhD; Phone Number: +306946536065; Email: dzouzoulas@hotmail.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM A: Control Arm; (Ethicon) PDS II 1-0 double loop suture material with a 48mm needle	Device: (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
Experimental: ARM B: Intervention Arm; Duramesh suture with a 48mm needle	Device: DURAMESH; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	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.	Fifth postoperative day after randomization

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Dimitrios Tsolakidis, Dr. Prof., Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Incisional Hernia
• Other Study ID Numbers: 2026- Β230-AN-564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of IPD only after contact with the principal investigator for the synthesis of future studies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No