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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07489820
Eligibility Criteria:
Inclusion Criteria:
* Adult patient;
* Patient scheduled to undergo abdominoperineal resection for adenocarcinoma of the lower and very lower rectum following chemoradiotherapy (50 Gy over 5 weeks);
* Patients capable of following the clinical trial protocol and who have provided written informed consent to participate in the clinical trial;
* Patients enrolled in the social security system or eligible for coverage;
Exclusion Criteria:
* Patients scheduled to undergo a salvage abdominoperineal resection for squamous cell carcinoma following chemoradiotherapy;
* Patients scheduled to undergo an abdominoperineal resection for adenocarcinoma of the very low rectum without neoadjuvant therapy;
* Patients with a known allergy to the dressing;
* Patients with a contraindication to the use of the PICO 7® dressing:
* Malignancy within the wound bed or at the wound margins;
* Previously confirmed, untreated osteomyelitis;
* Non-enteric, unexplored fistulas;
* Necrotic tissue with pressure ulcers;
* Exposed arteries, veins, nerves, or organs;
* Exposed anastomotic sites;
* Patients participating in another clinical research protocol that could affect the objectives of this clinical trial;
* Patients already randomized in this clinical trial;
* Pregnant patients, women in labor, breastfeeding women, or women of childbearing age not using effective contraception\*;
* Patients under guardianship, conservatorship, or deprived of their liberty;
* Patients under an activated future protection order;
* Patients under family authorization;
* Patients under judicial protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07489820
Study Brief:
Protocol Section:
NCT07489820