NCT03781206

Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.

Detailed description

Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith\&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).

Conditions

• Stoma Site Infection

Interventions

Type	Name	Description
DEVICE	PICO™ 7	PICO™ system (Smith\&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.

Timeline

• Start date: 2019-07-18
• Primary completion: 2021-03-01
• Completion: 2021-06-01
• First posted: 2018-12-19
• Last updated: 2021-02-05

Locations

1 site across 1 country: Italy