Clinical trial · Interventional
Fascial Abdominal Closure Evaluation
A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies
NCT07683546CI-TRIAL-00116846FACEnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Duramesh | — | UNRESOLVED | — |
| Hernia Incisional | — | UNRESOLVED | — |
| Suture Materials | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DURAMESH | Device | — | UNRESOLVED |
| (Ethicon) PDS II 1-0 double loop | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM A: Control Arm
- description
- (Ethicon) PDS II 1-0 double loop suture material with a 48mm needle
- interventionNames
- Device: (Ethicon) PDS II 1-0 double loop
- type
- EXPERIMENTAL
- label
- ARM B: Intervention Arm
- description
- Duramesh suture with a 48mm needle
- interventionNames
- Device: DURAMESH
Primary outcomes (1)
- measure
- Incidence of incisional hernia
- timeFrame
- Up to 12 months after randomization
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.