Not yet recruitingNAINTERVENTIONAL

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

This study is investigating a special type of dressing that uses gentle suction, called Negative Pressure Wound Therapy (PICO 7®), to see if it helps wounds heal better after a bowel cancer operation. This operation, called an abdominoperineal resection, removes part of the bowel and anus. Many patients needing this surgery have received radiotherapy beforehand, which can sometimes make wound healing more difficult. The study compares two groups: one using the special suction dressing and another using standard stitches. Researchers want to find out if the suction dressing can reduce wound healing problems, which can be a common concern for patients after this surgery. The goal is to improve recovery for people with certain types of bowel cancer.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre Hospitalier Departemental Vendee

Enrolment target

100

Start

01 May 2026

Estimated completion

15 Jun 2029

Adenocarcinoma (NOS)

What is this study about?

This study is looking into ways to help wounds heal better after a major operation called an abdominoperineal resection. This surgery is done to remove certain types of bowel cancer, specifically those in the lower part of the bowel, when other treatments aren't suitable. During this operation, surgeons remove the lowest part of the bowel and the anus, and then create a stoma (a new opening on the tummy for waste to leave the body). The area where the anus used to be is then closed with stitches.

Many patients who need this surgery have already had treatments like chemotherapy and radiotherapy. While these treatments are very important for fighting cancer, radiotherapy can sometimes make it harder for the wound to heal afterwards. This can lead to complications such as infections. The surgeons usually close the wound with stitches, but sometimes advanced techniques are used. This study is focusing on a simpler method of closing the wound with stitches.

Recently, a special type of dressing that uses gentle suction, called Negative Pressure Wound Therapy (PICO 7®), has been developed. This dressing works by gently removing fluid and other materials from the wound, which doctors hope will help it heal better and reduce the risk of infection. The aim of this study is to carefully compare this special dressing with standard wound closure to see if it truly helps wounds heal more effectively after this specific cancer surgery, especially for patients who have had radiotherapy.

Key takeaways

This study compares a special suction dressing (PICO 7®) with standard wound care.
It's for patients having bowel cancer surgery (abdominoperineal resection) who have had radiotherapy.
The aim is to improve wound healing and reduce complications after surgery.
Radiotherapy can make wound healing more difficult, so new approaches are being tested.
Participation involves either receiving the special dressing or standard stitches, with follow-up appointments.
The study seeks to find better ways to help patients recover after this specific cancer surgery.

Who may be eligible?

To join this study, you need to be an adult patient who is going to have an operation called an abdominoperineal resection for a specific type of bowel cancer (adenocarcinoma of the lower or very lower rectum). It's important that you have already received a course of radiotherapy before your surgery. You also need to be able to understand the study information and give your written permission to take part, and be eligible for the UK's social security system.

There are also some reasons why you wouldn't be able to join. For example, if your surgery is for a different type of cancer, or if you haven't had radiotherapy before your operation. You also can't join if you are allergic to the special dressing, or if you have certain conditions in or around your wound, such as a major infection or exposed blood vessels. If you are pregnant, breastfeeding, or taking part in another study that might affect these results, you would also not be able to participate. Lastly, certain legal situations, like being under guardianship, would prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 or over)?
Are you having abdominoperineal resection for bowel cancer (adenocarcinoma)?
Have you had radiotherapy before your surgery?
Are you able to agree to take part in the study in writing?
Do you have any known allergies to wound dressings?
Do you have any serious infections or exposed blood vessels in your wound area?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups: one group will receive the special suction dressing (PICO 7®) on your wound after surgery, and the other group will have your wound closed with standard stitches. Doctors will regularly check your wound healing during your hospital stay and at follow-up appointments. This will involve physical examinations and possibly taking pictures of your wound. Your participation will last until your wound has healed or for a set period after your surgery, which will be explained in full detail by the study team.

Potential risks and benefits

Potential benefits of taking part could include potentially better wound healing and a reduced risk of complications, especially if you are in the group receiving the special suction dressing. However, there's no guarantee that you will personally benefit. As with any medical procedure, there are potential risks, which could include skin irritation from the dressing, discomfort, or general risks associated with any surgical wound. The study dressing has specific exclusions, as detailed in the eligibility criteria, to minimise risks. You are free to withdraw from the study at any time without having to give a reason, and this will not affect your future medical care.

Locations (5)

Chu Amiens
Verified postcode
Amiens, France
Chu Angers
Verified postcode
Angers, France
Chd Vendee
Verified postcode
La Roche-sur-Yon, France
Hospital Saint Antoine (Aphp)
Verified postcode
Paris, France
Chu Rennes
Verified postcode
Rennes, France

Common questions

What is an abdominoperineal resection?

It's a type of surgery that removes the lower part of the bowel and the anus, often for bowel cancer. A stoma, an opening for waste, is then created on the tummy.

What is Negative Pressure Wound Therapy?

It's a special dressing system that uses gentle suction to help clean the wound and encourage healing by removing fluid and infectious material.

Why is radiotherapy mentioned?

Radiotherapy, an important cancer treatment, can sometimes make it harder for wounds to heal afterwards, so this study focuses on patients who have had it.

Will I know which treatment group I'm in?

The study will assign you to either the special dressing group or the standard stitch group. This helps ensure fair testing of the treatment.

How long will I be involved in the study?

Your involvement will continue until your wound is healed or for a specific, agreed period after your surgery, with regular checks by the study team.

How to find out more

Agnès DORION

agnes.dorion@ght85.fr 2 51 44 63 80 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.