Fascial Abdominal Closure Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DURAMESH, (Ethicon) PDS II 1-0 double loop.
- Who it may be relevant to
- Registry conditions: Hernia Incisional, Suture Materials, Duramesh. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Incidence of incisional hernia [Time frame: Up to 12 months after randomization]
Secondary outcome measures (3)
- 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]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07683546 · 2026- Β230-AN-564