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

Efficacy of the Er:YAG Laser Debridement on Patient-Reported Pain and Bacterial Load in Chronic Wounds

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03182582
Enrollment
22
Registered
2017-06-09
Start date
2017-01-05
Completion date
2017-03-17
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Laser Debridement, Debridement

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.

Detailed description

Chronic wounds are a debilitating affliction, affecting a substantial portion of the population worldwide and incurring staggering healthcare economic costs (1,2). Included among chronic wounds are venous leg ulcers, which are known to cause considerable pain, and can impact patient quality of life, thereby complicating wound care (3). The exact pathophysiology and etiology of the prolonged course of chronic wounds are poorly understood, but are thought to be multi-factorial in nature. Given the exposure of chronic wounds to the environment, they harbor a diverse microbial flora. Specifically, there is evidence that biofilm produced by these microbes are a large contributor to their non-healing nature (4). Debridement is considered an integral part of wound management with its ability to remove necrotic tissue and bacterial biofilm, in addition to stimulating release of cytokines and growth factors that promote wound healing (5). However, sharp debridement, the gold standard in wound care, is often ineffective for painful wounds. The effect of lasers on wound healing have been well-studied both in in vitro and in vivo models. Beneficial effects of low-level laser therapy in wound healing in animal and human studies has been established. However, extrapolation of this data is limited by study design and light dosimetry (6). Laser energy used for surgical excision is a lesser-known debridement technique that has been largely limited to burn scar treatment (7,8,9,10). Lasers are electro-optical devices that emit a focused beam of intense monochromatic light in the visible and infrared radiation spectrums. Since their start in the 1960s, lasers have been successfully utilized in many fields of medicine. Lasers for wound debridement began in the 1970s, with the successful report of a continuous-beam carbon dioxide (CO2) laser used for skin graft preparation of infected decubitus ulcers (11). Laser debridement is based on the controlled vaporization of the superficial layers of the wound bed. This results in the removal of the tissue containing unwanted microbial and necrotic particles. The laser type and the number of passes performed determine the depth of tissue ablation (12). Unlike other methods dependent on the clinician's manual control, laser debridement is electronically controlled, improving precision and reducing the risk of healthy tissue damage. Advantages of laser debridement include precision and uniformity of tissue ablation, which reduces trauma to the wound bed, improving patient comfort. To reduce thermal damage to healthy tissue, several improvements in laser technology have been made over the years. By utilizing a pulsed-beam system, laser energy is delivered in high-power, rapid succession pulses, resulting in short duration and high temperature exposure of target tissue, thereby minimizing thermal injury. Erbium:YAG (Er:YAG) lasers, with a wavelength of 2940-nm are widely used in the dermatologic community for skin resurfacing, for anti-aging and acne-related purposes (13). Skin ablation with the erbium laser is very precise, and allows for accurate assessment of the resurfacing depth (12,14,15). Since Er:YAG laser energy has greater than twelve times more water absorption efficiency than CO2 lasers, water in the tissue is rapidly expanded to eject the charred debris from the wound surface without leaving behind a necrotic eschar (12,16,17). The Er:YAG laser provides distinct advantages in precise ablation control and the reduction of residual necrotic tissue burden with minimal procedural discomfort, making the Er:YAG laser the most suitable device for laser wound debridement. Preliminary studies demonstrate remarkable patient pain reduction after laser debridement, resulting in more thorough removal of necrotic tissue and biofilm/bacterial load. Additionally, the extent of laser debridement is determined by the laser settings, as opposed to the individual operator's dexterity and skill, thereby providing better control over the wound bed preparation, producing more predictable and reproducible outcomes.

Interventions

DEVICEErbium: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.

PROCEDUREScalpel/Curette Debridement

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

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

The investigator is blinded to which patient is receiving sharp or laser debridement as his/her first treatment.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain With DebridementDay 1 of the respective procedure (immediately following)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.
Bacterial Load Pre- and Post-Laser DebridementDay 1 of the laser procedure (immediately before and after)Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. CFU = Colony Forming Units.
Bacterial Load Pre- and Post-Sharp DebridementDay 1 of the sharp procedure (immediately before and after)Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement

Secondary

MeasureTime frameDescription
Patient Preference2 weeksPatient-reported preference of debridement type one week after study completion, reported as the count of participants that preferred either method.
Percent Change in Wound Size- Immediately Post-debridementDay 1 of the respective procedure (immediately after)The mean wound size increased immediately after debridement in both Groups, compared to the mean wound size before the debridement.
Percent Change in Wound Size - 1 Week Post-debridement1 week following respective procedureThe mean percent change in wound size 1-week post-laser debridement was -20.8% ± 80.1%, as compared with -36.7% ± 54.3% 1-week post-sharp debridement (p = 0.6).

Participant flow

Participants by arm

ArmCount
Laser and Sharp Debridement
Laser debridement will be performed at 200-um until punctate bleeding is visualized. 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.
22
Total22

Baseline characteristics

CharacteristicLaser and Sharp Debridement
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
10 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
Age, Continuous68.2 years
STANDARD_DEVIATION 16.8
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
22 participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
4 Participants
Wound Etiology
Diabetic
4 Participants
Wound Etiology
Other
7 Participants
Wound Etiology
Venous
11 Participants
Wound size3.6 cm
STANDARD_DEVIATION 5.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 22
other
Total, other adverse events
0 / 220 / 22
serious
Total, serious adverse events
0 / 220 / 22

Outcome results

Primary

Bacterial Load Pre- and Post-Laser Debridement

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

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Laser DebridementBacterial Load Pre- and Post-Laser DebridementNegative0 Participants
Laser DebridementBacterial Load Pre- and Post-Laser Debridement<10^5 CFU/g6 Participants
Laser DebridementBacterial Load Pre- and Post-Laser Debridement>=10^5 CFU/g16 Participants
Sharp DebridementBacterial Load Pre- and Post-Laser DebridementNegative2 Participants
Sharp DebridementBacterial Load Pre- and Post-Laser Debridement<10^5 CFU/g11 Participants
Sharp DebridementBacterial Load Pre- and Post-Laser Debridement>=10^5 CFU/g9 Participants
Primary

Bacterial Load Pre- and Post-Sharp Debridement

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

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Laser DebridementBacterial Load Pre- and Post-Sharp DebridementNegative0 Participants
Laser DebridementBacterial Load Pre- and Post-Sharp Debridement<10^5 CFU/g12 Participants
Laser DebridementBacterial Load Pre- and Post-Sharp Debridement>=10^5 CFU/g10 Participants
Sharp DebridementBacterial Load Pre- and Post-Sharp DebridementNegative5 Participants
Sharp DebridementBacterial Load Pre- and Post-Sharp Debridement<10^5 CFU/g10 Participants
Sharp DebridementBacterial Load Pre- and Post-Sharp Debridement>=10^5 CFU/g7 Participants
Primary

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.

Time frame: Day 1 of the respective procedure (immediately following)

ArmMeasureValue (MEAN)Dispersion
Laser DebridementPain With Debridement3.0 units on a scaleStandard Deviation 1.7
Sharp DebridementPain With Debridement4.8 units on a scaleStandard Deviation 2.6
Comparison: A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.p-value: 0.003Paired t test
Secondary

Patient Preference

Patient-reported preference of debridement type one week after study completion, reported as the count of participants that preferred either method.

Time frame: 2 weeks

Population: Survey respondents were included in the analysis.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Laser DebridementPatient PreferencePrefer laser9 Participants
Laser DebridementPatient PreferencePrefer sharp6 Participants
Laser DebridementPatient PreferenceUnsure2 Participants
Secondary

Percent Change in Wound Size - 1 Week Post-debridement

The mean percent change in wound size 1-week post-laser debridement was -20.8% ± 80.1%, as compared with -36.7% ± 54.3% 1-week post-sharp debridement (p = 0.6).

Time frame: 1 week following respective procedure

ArmMeasureValue (MEAN)Dispersion
Laser DebridementPercent Change in Wound Size - 1 Week Post-debridement-20.8 percent changeStandard Deviation 80.1
Sharp DebridementPercent Change in Wound Size - 1 Week Post-debridement-36.7 percent changeStandard Deviation 54.3
Secondary

Percent Change in Wound Size- Immediately Post-debridement

The mean wound size increased immediately after debridement in both Groups, compared to the mean wound size before the debridement.

Time frame: Day 1 of the respective procedure (immediately after)

ArmMeasureValue (MEAN)Dispersion
Laser DebridementPercent Change in Wound Size- Immediately Post-debridement40.2 percent changeStandard Deviation 95
Sharp DebridementPercent Change in Wound Size- Immediately Post-debridement63.4 percent changeStandard Deviation 96.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026