Clinical trial NCT06690749: Using Skin Blood Flow to Measure the Effect of Different Doses of Negative Pressure Therapy
Official title: Effect of Negative Pressure Therapy on Skin Blood Flow Responses in the Scar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Scars
Keywords: Scar
Laser Doppler
Tensile stresses
Capillaries
Cupping
Lead sponsor: Asia University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study design and setting sample were drawn from patients randomly assigned to one of three parallel groups, initially in a 1:1:1 ratio to invite the subject to receive either NPT dosage.
Primary purpose: TREATMENT

Brief summary: Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF. However, it is unclear what dosage of NPT is most effective in treating scars.

This study compared NPT dosages of -105 mmHg, -125 mmHg, and -145 mmHg to assess the impact of NPT treatment on SBF in scar tissue and the correlation of NPT. If participants experience any symptoms of discomfort, NPT can be discontinued immediately.

36 scarred subjects were recruited to assess the efficacy of various NPT interventions. SBF applications are defined as perfusion levels instantly affecting NPT, and termination is defined as SBF after NPT.

The study runs from May 11, 2022, to May 11, 2023, at Asia University Hospital.

This study was funded by the National Science and Technology Council, Taiwan (NSTC 112-2221-E-468-004)

The main contact was Chi-Wen Lung, the person in charge of a college or university department of Product Design, Asia University, Taichung 413305, Taiwan.Email address: cwlung@asia.edu.tw

Detailed description: Introduction. Skin blood flow (SBF) is crucial for transporting nutrients during healing to treat scarring. Negative pressure therapy (NPT) is a promising option to enhance SBF.

This study's hypothesis was that NPT can enhance SBF in scar tissue and that the specific NPT dose affects this effect. The purpose of this study was to confirm the different dosages of NPT applied to scar tissue by comparing the blood flow before and after the effects of different NPT dosages. This will also contribute to the emerging field of scar treatment and provide evidence-based recommendations.

All recruited participants were approached to participate in a research study investigating the effects of NPT in a double-blind, parallel-group study on scar healing. This study used three negative pressure changes at -105, -125 mmHg, and -145 mmHg at 10 min. The suction method created a negative pressure in the cup using an electronic negative-pressure device (Medi Pump TC-2000V; Anest Iwata Sparmax Co., Ltd., Taipei, Taiwan). A cup with an inner diameter of 45 mm and outer diameter of 53 mm was used for cupping therapy. Each side of the cup rim had a width of 4 mm; therefore, no pain was caused by the cup rim.

Pearson product-moment correlation analysis was used to determine the correlations between the SBF-Baseline, SBF-Application, and SBF-Termination factors.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Wounds must have been present for at least 21 days.
* The participants were in the proliferation or remodeling phase.
* Within nine months of skin injury.

Exclusion Criteria:

* Incomplete wound healing.
* leakage of tissue fluid.
* Participants of the Edema.
* The other short-term treatment plans (pressure garments, radiotherapy, steroids, and cryotherapy).

Primary outcomes:
measure: Skin Blood Flow
timeFrame: Three minutes before to three minutes after negative pressure treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University Hospital
Study officials:
References: