Fascial Abdominal Closure Evaluation

NCT07683546 | Not Yet Recruiting

• 1 other identifier: 2026- Β230-AN-564
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Conditions

Duramesh; Hernia Incisional; Suture Materials

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia

  Clinical or radiological detected

  Up to 12 months after randomization

Secondary Outcomes (3)

• 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

  Fifth postoperative day after randomization

Study Arms (2)

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

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

ARM B: Intervention Arm

(Ethicon) PDS II 1-0 double loop DEVICE

(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

ARM A: Control Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Dimitrios Tsolakidis, Dr. Prof.

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Zouzoulas, MD, MSc, PhD

CONTACT

+306946536065; dzouzoulas@hotmail.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecological Oncologist, MSc, PhD, FEBS-BS, FESGO-EBCOG

Model Details: * 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).

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share