An interventional study of Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) and Direct perineal skin suture in Adenocarcinoma (NOS), sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Treatment
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 of the anal canal that does not respond to chemoradiotherapy.
Most often, treatment for non-metastatic adenocarcinoma of the lower and very lower rectum is part of a therapeutic sequence that includes neoadjuvant chemoradiotherapy followed by surgery 7 to 12 weeks later. Recently, the GRECCAR group (Rectal Surgery Research Group) published the results of the Prodigy 23 study demonstrating the benefit of intensification chemotherapy prior to neoadjuvant chemoradiotherapy.
This neoadjuvant regimen, and in particular chemoradiotherapy, can lead to impaired postoperative wound healing due to radiation-damaged tissue.
The incidence of impaired wound healing following chemoradiotherapy varies in the literature, with rates ranging from 30% to 70%. These wound complications can lead to local skin infections that may progress to pelvic sepsis, resulting in septic shock.
The perineum can be closed directly with a skin suture, but perineal reconstructions using a musculocutaneous flap have also been described. These reconstruction techniques require more extensive operating room coordination due to the need for a plastic and reconstructive surgery team. For this reason, the use of musculocutaneous flaps is not routine.
In recent years, pharmaceutical companies have developed a negative-pressure wound therapy system that allows for the absorption of infectious material and exudate through the wound. This system is intended to reduce surgical site infections. Results in the literature are inconsistent, with varying indications.
Rather et al. report a nearly 40% improvement in wound healing using a negative pressure therapy system on a closed perineal wound. In the literature review published by Meyer et al. in 2021, positive results of this technique are reported, with a 25% to 30% improvement in wound healing.
These results are encouraging, but currently there are no studies with a high level of evidence analyzing this practice.
For this reason, it is necessary to evaluate negative pressure therapy on perineal scars following chemoradiotherapy and abdominoperineal resection.
620 studies on the registry are indexed under Adenocarcinoma; 148 are open to participants now.
This study's planned enrollment of 100 is above the median of 57 across 490 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Patients with a to the use of the PICO 7® dressing:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Direct perineal skin suture
Device: 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), considered to be mildly to moderately exudative, and can be used on sutured surgical wounds. For prophylaxis, the dressing is applied for a period of 14 days, with the dressing and pump replaced on the 7th day.
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.
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).
Time frame: 45-day
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2029, 36 months after the start.
Of 40 interventional studies with no phase under Adenocarcinoma, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 170. This study's planned 36 months is below that.
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Centre Hospitalier Departemental Vendee