An interventional study of DURAMESH and (Ethicon) PDS II 1-0 double loop in Hernia Incisional, Suture Materials and Duramesh, sponsored by Aristotle University Of Thessaloniki. Not yet recruiting. Open to female participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment
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
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.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 300 is above the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(Ethicon) PDS II 1-0 double loop suture material with a 48mm needle
Device: (Ethicon) PDS II 1-0 double loop
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
(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
Incidence of incisional hernia
Clinical or radiological detected
Time frame: Up to 12 months after randomization
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
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.
Time frame: Fifth postoperative day after randomization
No study locations are listed for this record.
Plan to share: No — Sharing of IPD only after contact with the principal investigator for the synthesis of future studies
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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