Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy (NPWT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Wound; Acute Wound
• Intervention / Treatment: Other: NPWT; Other: standard care group

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPWT; 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; 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.
Other: standard care group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing	Wound size will be measured before and after the intervention, using a ruler and photographic records.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	Pain quality will be evaluated before and after the intervention using the Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. The pain index will be recorded, and the type, frequency, and dosage of pain medication used during the enrollment process will be documented.	90days
Wound-related Quality of Life	The Wound-QoL-17 questionnaire will be used before and after the intervention to assess the quality of life related to the wound. The Wound-QoL-17 consists of 17 items across three domains: Physical, Psychological, and Daily Life. The responses are based on a 5-point Likert scale, where a higher score indicates poorer quality of life. The Cronbach's α for the original Wound-QoL-17 ranges from 0.71 to 0.916, while for the Chinese version, it ranges from 0.71 to 0.93, indicating good internal consistency (Cronbach's alpha).	90days
Self-reported Health Status	The PHQ-9 (Patient Health Questionnaire-9) will be used before and after the intervention to screen for and track symptoms of depression. The PHQ-9 consists of 9 questions, each evaluating depressive symptoms over the past two weeks. Responses are rated from "not at all" to "nearly every day", with the frequency of responses used to assess the severity of depression.	90days
Length of Hospital Stay for wound treatment	The number of days participants are hospitalized during the enrollment and follow-up periods due to their wound will be recorded.	90days
Cost Analysis	The cost of wound treatment during the enrollment and follow-up periods will be assessed, including: Direct wound dressing costs、Wound care technique fees、Wound-related surgery costs、Wound-related medication usage、Outpatient follow-up or dressing change costs.	90days
Complications and Adverse Events	The following will be monitored: Surgical Site Infection (SSI)、Wound dehiscence、Allergic reactions、Wound infection、Hematoma、Inflammation、Bleeding.	90days
Adhesion Issues for Dressing	This will include incidents of unintended dressing detachment, skin tear during dressing removal, and the methods of enhanced dressing fixation during treatment.	90days
Mortality Events	The cause and time of death for participants during the enrollment and follow-up periods will be recorded.	90days

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: BenQ Materials Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; wound care; Negative Pressure Wound Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: ID001; 000 (Other Identifier: YCTG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan is not public yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No