Duramesh, Hernia Incisional, Suture Materials
Conditions
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
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
DEVICEDURAMESH
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
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
* 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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of incisional hernia | Up to 12 months after randomization | Clinical or radiological detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Contacts
CONTACTDimitrios Zouzoulas, MD, MSc, PhD
PRINCIPAL_INVESTIGATORDimitrios Tsolakidis, Dr. Prof.
Aristotle University Of Thessaloniki
Outcome results
None listed