Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Clinical Trial

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

NCT: NCT07489820 · NOT_YET_RECRUITING

NCT IDNCT07489820
StatusNOT_YET_RECRUITING
Start Date2026-05-01
Completion2029-06-15

Brief 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.

Frequently Asked Questions

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

Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation is a clinical trial registered under NCT07489820. Current status: NOT_YET_RECRUITING.

What is the status of NCT07489820?

The current status of NCT07489820 (Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation) is: NOT_YET_RECRUITING.

When did Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation start?

Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation started on 2026-05-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.