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NCT Number: NCT07683546

Fascial Abdominal Closure Evaluation

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

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Key information

Conditions

Hernia Incisional Duramesh Hernia Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Suture Materials

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

(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

Primary outcomes

  1. Incidence of incisional hernia

    Time frame: Up to 12 months after randomization

    Clinical or radiological detected

Secondary outcomes

  1. Incidence of wound dehiscence

    Time frame: Up to 1 month after randomization

  2. Incidence of wound infection

    Time frame: Up to 1 months after randomization

  3. Visual Analogue Scale (VAS) for wound pain

    Time frame: Fifth postoperative day after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitrios Zouzoulas, MD, MSc, PhD

CONTACT

[email protected]

+306946536065

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies

Acronym: FACE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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