Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Negative Pressure Wound Therapy in Traumatic Skin Loss

NCT05653297

Post Traumatic Skin Loss

UNKNOWN

The Study of Wound Dressings for Portable NPWT

NCT03135964

Pressure Ulcer Diabetic Foot Ulcer

COMPLETED NA

Evaluate the Efficacy of the Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) After Surgery by Application of Negative Pressure Wound Therapy (NPWT) in Comparison to Standard Conventional Wound Therapy (SCWT) of the Clinical Routine

NCT01611207

Postoperative Abdominal Wounds Wound-healing Impairments

TERMINATED NA

Effect of Negative Wound Pressure on P.S

NCT06243328

Pressure Sores

NOT_YET_RECRUITING NA

Wound Bed Preparation for Diabetic Foot Ulcers

NCT05577104

Diabetic Foot

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Wound Acute Wound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NPWT

The NPWT group (experimental group) will include 80 participants. Wounds will be cleansed with sterile normal saline, followed by wound assessment and documentation. The Anscare SIMO Negative Pressure Wound Therapy (NPWT) System, a non-powered NPWT dressing, will then be applied.

Group Type EXPERIMENTAL

NPWT

Intervention Type 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.

standard care group

Thestandard care group will include 80 participants. Wounds will be cleansed with sterile normal saline and receive routine wound care, followed by wound assessment and documentation.

Group Type OTHER

standard care group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No