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NCT Number: NCT06911307

Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy

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.

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Key information

Conditions

Chronic Wound Acute Wound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Wound size >10 × 20 cm.

Treatment and study plan

Standard Care Group

Other

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.

NPWT

Other

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.

Primary outcomes

  1. wound healing

    Time frame: 90days

    • 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).

Secondary outcomes

  1. Pain Assessment

    Time frame: 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.

  2. Wound-related Quality of Life

    Time frame: 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).

  3. Self-reported Health Status

    Time frame: 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.

  4. Length of Hospital Stay for wound treatment

    Time frame: 90days

    The number of days participants are hospitalized during the enrollment and follow-up periods due to their wound will be recorded.

  5. Cost Analysis

    Time frame: 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.

  6. Complications and Adverse Events

    Time frame: 90days

    The following will be monitored: Surgical Site Infection (SSI)、Wound dehiscence、Allergic reactions、Wound infection、Hematoma、Inflammation、Bleeding.

  7. Adhesion Issues for Dressing

    Time frame: 90days

    This will include incidents of unintended dressing detachment, skin tear during dressing removal, and the methods of enhanced dressing fixation during treatment.

  8. Mortality Events

    Time frame: 90days

    The cause and time of death for participants during the enrollment and follow-up periods will be recorded.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • BenQ Materials Corporation

Registry information

Official study title

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

Acronym: NPWT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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