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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
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.
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).
Time frame: 90days
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90days
Complications and Adverse Events
The following will be monitored: Surgical Site Infection (SSI)、Wound dehiscence、Allergic reactions、Wound infection、Hematoma、Inflammation、Bleeding.
Time frame: 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.
Time frame: 90days
Mortality Events
The cause and time of death for participants during the enrollment and follow-up periods will be recorded.
Time frame: 90days
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