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

NCT03182582 | Completed Results FDA Device

• 1 other identifier: IRB-35141
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Laser Debridement; Debridement

Outcome Measures

Primary Outcomes (3)

• Pain With Debridement

  Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is used in our study to measure the intensity or frequency of pain. We have used Numerical Rating Scale (NRS), variant of VAS, which is a validated, uni-dimensional measure of pain intensity reported on an 11-point numeric scale. The scores were reported from "0" to "10," with "0" representative of "no pain," and "10" representative of the "worst possible pain".

  Day 1 of the respective procedure (immediately following)

• Bacterial Load Pre- and Post-Laser Debridement

  Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. CFU = Colony Forming Units.

  Day 1 of the laser procedure (immediately before and after)

• Bacterial Load Pre- and Post-Sharp Debridement

  Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement

  Day 1 of the sharp procedure (immediately before and after)

Secondary Outcomes (3)

• Patient Preference

  2 weeks

• Percent Change in Wound Size- Immediately Post-debridement

  Day 1 of the respective procedure (immediately after)

• Percent Change in Wound Size - 1 Week Post-debridement

  1 week following respective procedure

Study Arms (2)

Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement

ACTIVE COMPARATOR

During the first treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. During the second treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing. Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment.

Device: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement; Procedure: Scalpel/Curette Debridement

Week 1 - Scalpel/Curette Debridement

ACTIVE COMPARATOR

During the first treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. During the second treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing. Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment.

Device: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement; Procedure: Scalpel/Curette Debridement

Interventions

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

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.

Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement; Week 1 - Scalpel/Curette Debridement

Scalpel/Curette Debridement PROCEDURE

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

Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement; Week 1 - Scalpel/Curette Debridement

Eligibility Criteria

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

You may qualify if:

• Aged eighteen years or older
• Having a chronic wound (as defined by lack of at least 50% reduction in wound surface area over a period of four weeks)
• No clinical evidence of active wound bed infection
• No exposure of any vital structure (i.e., tendon, bone, vessel)
• Has signed the informed consent form prior to any study protocol related procedure
• Willing and able to adhere to protocol requirements

You may not qualify if:

• Any unstable medical condition that would cause the study treatment to be detrimental to the subject, as judged by the Principle Investigator
• Documented medical history of significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease would impede the subject's participation, as judged by the Principle Investigator
• Documented medical history of immunosuppression, immune deficiency disorder, or currently using immunosuppressive medications
• Having clinical presentation of active osteomyelitis
• Pregnancy or lactation
• Participation in another clinical study involving ulcers within thirty days prior to enrollment

Sponsors & Collaborators

• Stanford University: lead

Related Publications (17)

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  PMID: 8491995 BACKGROUND

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  PMID: 10812528 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

4 different surgeons carried out wound debridement and tissue sampling; therefore, techniques could vary in wound bed preparation and tissue sampling. Also, wound measurements suffer from variations in technique and inter-observer subjectivity.

Results Point of Contact

• Title: Geoffrey C. Gurtner, MD
• Organization: Stanford University

ggurtner@stanford.edu

650-736-2776

Study Officials

• Shannon Meyer, CCRC

  Clinical Trial Coordinator

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator is blinded to which patient is receiving sharp or laser debridement as his/her first treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A portion of the patients will be randomized to sharp debridement first, then laser for the second debridement. The other portion will undergo this in the opposite order.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 9, 2017
• Study Start: January 5, 2017
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: March 30, 2020
• Results First Posted: April 17, 2018

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share