Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standard care group, NPWT.
- Who it may be relevant to
- Registry conditions: Chronic Wound, Acute Wound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy: a Randomized Controlled Trial
Overview
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
- Other standard 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. - Other NPWT
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 outcome measures
- wound healing [Time frame: 90days]
Secondary outcome measures (8)
- Pain Assessment [Time frame: 90days]
- Wound-related Quality of Life [Time frame: 90days]
- Self-reported Health Status [Time frame: 90days]
- Length of Hospital Stay for wound treatment [Time frame: 90days]
- Cost Analysis [Time frame: 90days]
- Complications and Adverse Events [Time frame: 90days]
- Adhesion Issues for Dressing [Time frame: 90days]
- Mortality Events [Time frame: 90days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06911307 · ID001 · 000