Chronic Wound, Acute Wound
Conditions
Keywords
Negative Pressure Wound Therapy;, wound care, randomized controlled trial
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.
Interventions
OTHERstandard 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.
OTHERNPWT
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.
Sponsors
BenQ Materials Corporation
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Outcome results
None listed