Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy

Not Applicable

Not yet recruiting

• Conditions: Chronic Wound; Acute Wound

• Registration Number: NCT06911307
• Lead Sponsor: Taipei Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-02
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-05-01
• Primary Completion: 2025-05-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
wound healing	90days	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).

Secondary Outcome Measures

Name	Time	Method
Pain Assessment	90days	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.
Cost Analysis	90days	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.
Complications and Adverse Events	90days	The following will be monitored: Surgical Site Infection (SSI)、Wound dehiscence、Allergic reactions、Wound infection、Hematoma、Inflammation、Bleeding.
Adhesion Issues for Dressing	90days	This will include incidents of unintended dressing detachment, skin tear during dressing removal, and the methods of enhanced dressing fixation during treatment.
Mortality Events	90days	The cause and time of death for participants during the enrollment and follow-up periods will be recorded.
Wound-related Quality of Life	90days	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).
Self-reported Health Status	90days	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.
Length of Hospital Stay for wound treatment	90days	The number of days participants are hospitalized during the enrollment and follow-up periods due to their wound will be recorded.