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

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. 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.

Conditions

• Adenocarcinoma (NOS)

Interventions

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.

OTHER

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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee

  lead OTHER

Principal Investigators

• Emeric ABET, Dr. · CHD Vendee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2029-06-15

Completion

2029-06-15

Countries

• France

Study Locations