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

NCT06690749 | Completed

• 2 other identifiers: CRREC-111-017NSTC 112-2221-E-468-004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertrophic Scars

Keywords

Scar; Laser Doppler; Tensile stresses; Capillaries; Cupping

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Negative pressure therapy dosage

EXPERIMENTAL

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

Device: Negative pressure therapy, NPT

Interventions

Negative pressure therapy, NPT 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.

Also known as: -105 mmHg NPT, -125 mmHg NPT, -145 mmHg NPT

Negative pressure therapy dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Asia University: lead

Study Sites (1)

Asia University Hospital

Taichung, Taiwan, 222, Taiwan

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 15, 2024
• Study Start: May 11, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: November 15, 2024

Record last verified: 2022-05

Locations

TW (1)