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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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
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