Adenocarcinoma (NOS)AAPICONCT07489820
Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
A study testing Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) and Direct perineal skin suture in people with Adenocarcinoma (NOS), run by Centre Hospitalier Departemental Vendee at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma (NOS)
- What is being tested?
- Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) and Direct perineal skin suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Jul 2026to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Chu Amiens
Amiens, 80054
Charles SABBAGH, Dr.
- Not yet recruiting
Chu Angers
Angers, 49933
Aurélien VENARA, Dr.
- Recruiting
Chd Vendee
La Roche-sur-Yon, 85925
Emeric ABET, Dr.
- Not yet recruiting
Hospital Saint Antoine (Aphp)
Paris
Yann PARC, Pr.
- Not yet recruiting
Chu Rennes
Rennes, 35033
Aude MERDRIGNAC, Dr.
About this study
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.
Read more
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.
- Conditions
- Adenocarcinoma (NOS)
- Being tested
- Direct perineal skin suturing with negative pressure wound therapy (PICO 7®), Direct perineal skin suture
- Keywords
- adenocarcinoma, abdominal-perineal resection, negative pressure wound therapy
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct perineal skin suturing with negative pressure wound therapy (PICO 7®)Device
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.
Direct perineal skin sutureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard: Direct perineal skin suture; | Sham comparator | Not described Receives: Other: Direct perineal skin suture |
| Experimental: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) | Experimental | Not described Receives: Device: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 45-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start10 Jul 2026
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma (NOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeric ABET, Dr., Principal investigator, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489820
- Sponsor's protocol ID
- CHD24_0008
- Acronym
- AAPICO
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
- ClinicalTrials.gov ID
- NCT07489820
- Acronym / sponsor ID
- AAPICO / CHD24_0008
- Conditions
- Adenocarcinoma (NOS)
- Keywords
- adenocarcinoma, abdominal-perineal resection, negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard: Direct perineal skin suture; | Sham comparator | Other: Direct perineal skin suture |
| Experimental: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) | Experimental | Device: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (17 listed)
- 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:
- Patients participating in another clinical research protocol that could affect the objectives of this clinical trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) |
| Direct perineal skin suturePatients 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. | Other | Standard: Direct perineal skin suture; |
Primary outcome
The occurrence of at least one infectious complication at the perineal incision site within 45 days of the procedure.
Time frame: 45-day
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emeric ABET, Dr. principal investigator
CHD Vendee
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) and Direct perineal skin suture in people with Adenocarcinoma (NOS), run by Centre Hospitalier Departemental Vendee at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnès DORION (2 51 44 63 80 ext. +33, agnes.dorion@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of at least one infectious complication at the perineal incision site within 45 days of the procedure. (time frame: 45-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.