Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
standard care group
Other interventionThe 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.
NPWT
Other interventionThe 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: NPWTExperimental treatment 1 intervention
Group B: standard care groupOther 1 intervention
Trial outcomes
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).
Time frame
90daysSecondary outcomes
1
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
90days2
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
90days3
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
90days4
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
90daysLocations
Sponsors and contacts
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Taipei Medical University
Lead sponsor
BenQ Materials Corporation
Collaborator
Source ClinicalTrials.gov
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