Negative pressure wound therapy after abdominoperineal resection for lower rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines direct perineal skin suturing with a PICO 7 negative pressure wound therapy dressing after abdominoperineal resection for non-metastatic adenocarcinoma of the lower rectum. Eligible participants are adults receiving the procedure after chemoradiotherapy and who can consent. The trial aims to see if the negative pressure dressing improves perineal wound healing compared with standard closure. Follow-up assesses wound healing outcomes and safety related to the dressing, within the surgical care pathway at multiple centers in France. The study does not specify a separate control group in the provided details and focuses on a specific dressing approach during perineal closure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chd Vendee
  La Roche-sur-Yon, France Recruiting
• Chu Amiens
  Amiens, France Not yet recruiting
• Chu Angers
  Angers, France Not yet recruiting
• Hospital Saint Antoine (Aphp)
  Paris, France Not yet recruiting
• Chu Rennes
  Rennes, France Not yet recruiting

Study contacts

• Principal investigator: Emeric ABET, Dr. — CHD Vendee
• Study coordinator: Agnès DORION
• Email: agnes.dorion@ght85.fr
• Phone: 2 51 44 63 80

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.