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Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds

NCT03182582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-03-30

Study results available
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Summary

Bacterial load is frequently associated with impaired healing of chronic wounds. As well, sharp debridement is often associated with pain, causing patient distress, and thereby occasionally contributing to inadequacy of debridement, leading to a delay in wound healing. The purpose of this study is to assess the efficacy of the Sciton Laser in reducing bacterial load and patient distress in patients with chronic wounds, in efforts to expedite the wound healing process.

Conditions

  • Wound Open
  • Chronic Venous Hypertension (Idiopathic) With Ulcer
  • Diabetic Foot Ulcer

Interventions

DEVICE

Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement

Laser debridement entailed usage of an Er:YAG laser, employing the JOULE® machine (Sciton, Inc., Palo Alto, California). Full-field ablation was performed using the 2940 nm Er:YAG Contour TRL Resurfacing® application with the following settings: fluence - 50 J/cm2, spot overlap - 50%, pattern repeat - 0.5 seconds, spot size - 3-mm (Figure 1). Debridement was carried out until all fibrinous and/or necrotic tissues were removed, and healthy, bleeding tissue was visualized.

PROCEDURE

Scalpel/Curette Debridement

Using a scalpel/curette, each patient's chronic wound is debrided until healthy, viable tissue is noted.

Sponsors & Collaborators

Principal Investigators

  • Shannon Meyer, CCRC · Clinical Trial Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2017-03-17
Completion
2017-03-17
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182582 on ClinicalTrials.gov