Using Skin Blood Flow to Measure the Effect of Different Doses of Negative Pressure Therapy

NCT ID: NCT06690749

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2023-05-11

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.

Conditions

Hypertrophic Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative pressure therapy dosage

A negative pressure value gap of 20mmHg was used between the each groups.

Group Type: EXPERIMENTAL

Negative pressure therapy, NPT

Intervention Type: DEVICE

We designed the experiment based on current clinical cases involving negative pressure therapy (NPT) for wounds and related animal studies. In this study, we applied three levels of negative pressure: -105 mmHg, -125 mmHg, and -145 mmHg, each for 10 minutes.

The -125 mmHg dosage was chosen based on findings from a previous study. Similar studies that utilized increments and decrements of 20 mmHg informed our research.

Moreover, to prevent any damage to new capillaries, we established a base dosage of -125 mmHg and refrained from using negative pressure levels exceeding -150 mmHg.

Interventions

Negative pressure therapy, NPT

We designed the experiment based on current clinical cases involving negative pressure therapy (NPT) for wounds and related animal studies. In this study, we applied three levels of negative pressure: -105 mmHg, -125 mmHg, and -145 mmHg, each for 10 minutes.

The -125 mmHg dosage was chosen based on findings from a previous study. Similar studies that utilized increments and decrements of 20 mmHg informed our research.

Moreover, to prevent any damage to new capillaries, we established a base dosage of -125 mmHg and refrained from using negative pressure levels exceeding -150 mmHg.

Intervention Type: DEVICE

Other Intervention Names

-105 mmHg NPT; -125 mmHg NPT; -145 mmHg NPT

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asia University Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

NSTC 112-2221-E-468-004

Identifier Type: OTHER

Identifier Source: secondary_id

CRREC-111-017

Identifier Type: -

Identifier Source: org_study_id