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

Effect of Negative Pressure Therapy on Skin Blood Flow Responses in the Scar

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

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scars
• Intervention / Treatment: Device: Negative pressure therapy, NPT

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 222
    • Asia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Negative pressure therapy dosage; A negative pressure value gap of 20mmHg was used between the each groups.

Device: 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.; Other Names: -105 mmHg NPT; -125 mmHg NPT; -145 mmHg NPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Blood Flow	The skin blood flow (SBF) before negative pressure therapy (NPT) recorded from 30 seconds to 1 minute was defined as the SBF-termination value. The 0-30 seconds SBF before NPT was the baseline SBF-Baseline. The records of the calculated NPT value from 10 minutes to 10.5 min are defined as application value. The record with 30 seconds to 1 minute after NPT is defined as the SBF-termination value. The evaluation standard is the 30-second average.	Three minutes before to three minutes after negative pressure treatment

Collaborators and Investigators

• Sponsor: Asia University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Scar; Cupping; Laser Doppler; Tensile stresses; Capillaries
• Additional Relevant MeSH Terms: Pathologic Processes; Cicatrix; Fibrosis; Cicatrix, Hypertrophic
• Other Study ID Numbers: CRREC-111-017; NSTC 112-2221-E-468-004 (Other Identifier: National Science and Technology Council, Taiwan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The raw data values of the skin blood flow study result in the Clinical Study Report (CSR) will be provided to the submitting journal when the relevant journal publishes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No