Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT04584957
Eligibility Criteria:
Inclusion Criteria:
All patients subjected to midline incision (xiphoid-pubic/sub-xiphoid/umbilical-pubic incision) with:
* Moderate/Severe (Aletti score ≥3) Modified surgical complexity score in:
* Ovarian cancer: primary debulking surgery (PDS) or interval debulking surgery (IDS) (minimum total hysterectomy+bilateral salpingo-oophorectomy+lymphadenectomy in early ovarian cancer \[EOC\] should be done to include the patient in the trial) or secondary debulking surgery at recurrence (SCS).
* Endometrial cancer FIGO stage IV or staging surgery for high risk endometrial cancer
* Uterine Sarcomas FIGO stage IIB-IV
* Previous history of pelvic or abdominal radiotherapy (even locally advanced cervical cancer \[LACC\] post neoadjuvant (NAD) therapies \[NAD chemo-radiation or chemotherapy alone\])
* Persistent or recurrent Cervical cancer
* Obesity (\>30 Kg/sqm) in all Aletti score surgery and in all FIGO stage malignancies
* Controlled diabetes mellitus in all Aletti score surgery and all FIGO stage malignancies
* Heavy smokers ≥ 20 cigarettes a day in all Aletti score surgery and all FIGO stage malignancies.
Exclusion Criteria:
* uncontrolled diabetes mellitus
* severe cardiac dysfunction
* pregnancy
* underweight (body mass index \[BMI\] \< 18.5 kg/sqm)
* long-term steroid use
* subcutaneous (e.g. Jackson Pratt) drainage positioning
* post-operative prophylactic use of antibiotics beyond the intraoperative short therapy
* contaminated (class III) and dirty/infected (class IV) incision \[10\]
* allergy to silver
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04584957
Study Brief:
Protocol Section:
NCT04584957