Health TrialsbyHealthPanel

Fascial Abdominal Closure Evaluation

ConditionsHernia IncisionalSuture MaterialsDuramesh
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorAristotle University Of Thessaloniki

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Midline laparotomies for gynecological malignancies

Age 18 - 85 years old

ECOG Performance status: 0 - 2

Disqualifiers

Pregnancy

Albumin < 3.5 g/dL

Previous history of any type of hernia

Previous midline incision (via laparotomy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: ARM A: Control ArmActive comparator 1 intervention
Group B: ARM B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of incisional hernia

Clinical or radiological detected

Time frame
Up to 12 months after randomization

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aristotle University Of Thessaloniki

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: