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L'essai clinique NCT07489820 (AAPICO) pour Adenocarcinoma (NOS) est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation (AAPICO) 100

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07489820 (AAPICO) est une étude interventionnel pour Adenocarcinoma (NOS). Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mai 2026, avec un objectif de 100 participants. Dirigée par Centre Hospitalier Departemental Vendee, l'étude devrait être terminée d'ici le 15 juin 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 mars 2026.
Résumé succinct
Abdomino-perineal resection is a surgical procedure involving the removal of the rectum and anus via abdominal and perineal approaches. During this procedure, a terminal colostomy is created and the perineum is closed. This procedure is indicated for patients with non-metastatic adenocarcinoma of the lower and very lower rectum (where preservation of the sphincter apparatus is not possible) or squamous cell carcinoma...Afficher plus
Titre officiel

Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation

Pathologies
Adenocarcinoma (NOS)
Autres identifiants de l'étude
  • AAPICO
  • CHD24_0008
Numéro NCT
NCT07489820
Date de début (réel)
2026-05-01
Dernière mise à jour publiée
2026-03-24
Date de fin (estimée)
2029-06-15
Inscription (estimée)
100
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
adenocarcinoma
abdominal-perineal resection
negative pressure wound therapy
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur facticeStandard: Direct perineal skin suture;
Direct perineal skin suture
Patients receive a skin suture that is checked daily during their hospital stay to ensure there are no local complications. Dressings are not routinely applied to the skin suture.
ExpérimentalExperimental: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®)
Direct perineal skin suturing with negative pressure wound therapy (PICO 7®)
The PICO 7® single-use negative pressure wound therapy system consists of a pump and two sterile dressings. The PICO 7® pump maintains a negative pressure of 80 mmHg (nominal) at the wound surface. Wound exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film. PICO 7® is designed for use on wounds measuring up to 400 cm³ (surface area x depth), consid...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
The occurrence of at least one infectious complication at the perineal incision site within 45 days of the procedure.
The 45-day period was chosen to allow for evaluation of the wound before resuming adjuvant therapy, particularly chemotherapy. To avoid worsening the patient's oncological prognosis, adjuvant therapy must be resumed between 6 and 8 weeks after surgery. A perineal infection will be defined by perineal discharge with a bacteriological culture and the initiation of antibiotic therapy, or the presence of a pelvic collection on an abdominal-perineal CT scan associated with a biological inflammatory syndrome (white blood cell count \> 10,000/mm³ and CRP \> 5 mg/L).
45-day
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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;

  • 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.

Centre Hospitalier Departemental Vendee logoCentre Hospitalier Departemental Vendee
Contact central de l'étude
Contact: Laura SOULARD, 02 51 08 05 82, [email protected]
5 Centres de l'étude dans 1 pays
Chu Amiens, Amiens, 80054, France
Charles SABBAGH, Dr., Investigateur principal
Chu Angers, Angers, 49933, France
Aurélien VENARA, Dr., Investigateur principal
Chd Vendee, La Roche-sur-Yon, 85925, France
Emeric ABET, Dr., Investigateur principal
Hospital Saint Antoine (Aphp), Paris, France
Yann PARC, Pr., Investigateur principal
Chu Rennes, Rennes, 35033, France
Aude MERDRIGNAC, Dr., Investigateur principal