Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy

NCT06911307 | Not Yet Recruiting

• 2 other identifiers: ID001000
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Negative Pressure Wound Therapy;; wound care; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• wound healing

  1. Wound size will be measured before and after the intervention, using a ruler and photographic records. 2. The occurrence and time of healing events will be documented. The modified TIME-H score will be used as the evaluation tool. This scoring system includes four main indicators: T (Tissue)、I (Infection)、M (Moisture)、E (Edge)、H (Healing).

  90days

Secondary Outcomes (8)

• Pain Assessment

  90days

• Wound-related Quality of Life

  90days

• Self-reported Health Status

  90days

• Length of Hospital Stay for wound treatment

  90days

• Cost Analysis

  90days

Study Arms (2)

NPWT

EXPERIMENTAL

The NPWT group (experimental group) will include 80 participants. Wounds will be cleansed with sterile normal saline, followed by wound assessment and documentation. The Anscare SIMO Negative Pressure Wound Therapy (NPWT) System, a non-powered NPWT dressing, will then be applied.

Other: NPWT

standard care group

OTHER

Thestandard care group will include 80 participants. Wounds will be cleansed with sterile normal saline and receive routine wound care, followed by wound assessment and documentation.

Other: standard care group

Interventions

standard care group OTHER

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.

standard care group

NPWT OTHER

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.

NPWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute wounds (wound duration \<4 weeks) or chronic wounds (wound duration ≥4 weeks).
• Wound depth \<2 cm.
• Age ≥18 years.
• Patients who have been evaluated and approved for participation by their attending physician.

You may not qualify if:

• Patients with unstable vital signs.
• Presence of ischemia in the wound or surrounding tissues.
• Fragile skin around the wound.
• Severe wound infection or necrotic tissue.
• Wound size \>10 × 20 cm.

Sponsors & Collaborators

• Taipei Medical University: lead
• BenQ Materials Corporation: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: April 4, 2025
• Study Start: May 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share