Incisional Negative Pressure Wound Therapy for Lower Intestinal Perforations

JRCT ID: jRCT1032230026

Registered date:16/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lower intestinal Perforations
• Date of first enrollment: 01/04/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients were managed with the NPWT device and compared to a historical control group managed with standard postoperative dressings. The patients were placed on NPWT at a pressure of -120 mmHg for 5 days, starting immediately after surgery or the day after surgery, with the wound closed with subcutaneous implantable sutures using a 4-0 PDS. NPWT was applied for a total of 10 days in all patients.The RENASYS wound care system was used as the NPWT device.

Outcome(s)

• Primary Outcome: Percentage of SSIs
• Secondary Outcome: Length of hospitalization Incidence of abdominal wall scar hernias

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with perforation of the lower gastrointestinal tract (cases of emergency surgery with open abdomen)
2) Age 20 years or older at the time of enrollment
3) Written consent to participate in the study has been obtained.

Exclude criteria

1) Patients whose life is judged to be difficult to save
2) Patients who are judged by the principal investigator or subinvestigator to be ineligible for the study
3) Patients whose consent cannot be obtained in the informed consent document

Related Information

• Primary Sponsor: yuhei tsukazaki