Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- The occurrence of at least one infectious complication at the perineal incision site within 45 days of the procedure.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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 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.
研究组 & 干预措施
Standard: Direct perineal skin suture;
干预措施: Direct perineal skin suture (Other)
Experimental: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®)
干预措施: Direct perineal skin suturing with negative pressure wound therapy (PICO 7®) (Device)
结局指标
主要结局
The occurrence of at least one infectious complication at the perineal incision site within 45 days of the procedure.
时间窗: 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).
次要结局
未报告次要终点