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Tests treatment safety and results for Adenocarcinoma (NOS)
Official title Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
ClinicalTrials.gov ID: NCT07489820
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient;
- Patient scheduled to undergo abdominoperineal resection for adenocarcinoma of the lower and very lower rectum following chemoradiotherapy (50 Gy over...
- 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;
You likely can't join if
- 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;
See the full eligibility 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;
- 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 assigned by chance 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- La Roche-sur-Yon, France
- Paris, France
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; La Roche-sur-Yon, France; Paris, France; Rennes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.