NCT06911307

Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy

Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the effectiveness of Non-powered Negative Pressure Wound Therapy (NPWT) on the healing of abdominal surgical wounds. It is designed as a randomized controlled trial with an experimental group (using NPWT) and a control group (conventional wound care). The study aims to recruit 160 participants: 80 with acute wounds and 80 with chronic wounds. Participants will be randomly assigned to either the experimental group (40 acute wounds, 40 chronic wounds) or the control group (40 acute wounds, 40 chronic wounds). The study will assess wound healing rates and speed, quality of life, self-perceived health status, pain levels, complications, and wound care costs using indicators. Effectiveness will be analyzed using Generalized Estimating Equations (GEE). The study anticipates that results will contribute to evaluating the effects of Non-powered NPWT on wound healing, quality of life, pain, and cost-effectiveness in patients with acute and chronic wounds.

Conditions

• Chronic Wound
• Acute Wound

Interventions

Type	Name	Description
OTHER	standard care group	The standard care (SC) group will also include 80 participants. Wounds will be cleansed with sterile normal saline and managed using conventional wound care techniques. Participants will undergo regular postoperative follow-ups to assess wound healing progression and secondary outcome measures.
OTHER	NPWT	The NPWT group will also include 80 participants. Wounds will be cleansed with sterile normal saline and coverd the SIMO NPWT dressing. Participants will undergo regular postoperative follow-ups to assess wound healing progression and secondary outcome measures.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-05-31
• Completion: 2026-03-31
• First posted: 2025-04-04
• Last updated: 2025-04-04