Trial Outcomes & Findings for Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds (NCT NCT03182582)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Day 1 of the respective procedure (immediately following)

Results posted on

2020-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Laser, Then Sharp 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.	Sharp, Then Laser 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.
Treatment 1 STARTED	12	10
Treatment 1 COMPLETED	12	10
Treatment 1 NOT COMPLETED	0	0
Treatment 2 STARTED	12	10
Treatment 2 COMPLETED	12	10
Treatment 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser and Sharp Debridement n=22 Participants 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.
Age, Categorical <=18 years	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=22 Participants
Age, Categorical >=65 years	10 Participants n=22 Participants
Age, Continuous	68.2 years STANDARD_DEVIATION 16.8 • n=22 Participants
Sex: Female, Male Female	18 Participants n=22 Participants
Sex: Female, Male Male	4 Participants n=22 Participants
Region of Enrollment United States	22 participants n=22 Participants
Wound Etiology Diabetic	4 Participants n=22 Participants
Wound Etiology Venous	11 Participants n=22 Participants
Wound Etiology Other	7 Participants n=22 Participants
Wound size	3.6 cm STANDARD_DEVIATION 5.6 • n=22 Participants

PRIMARY outcome

Timeframe: Day 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".

Outcome measures

Outcome measures
Measure	Laser Debridement n=22 Participants Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.	Sharp Debridement n=22 Participants Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
Pain With Debridement	3.0 units on a scale Standard Deviation 1.7	4.8 units on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: Day 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.

Outcome measures

Outcome measures
Measure	Laser Debridement n=22 Participants Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.	Sharp Debridement n=22 Participants Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
Bacterial Load Pre- and Post-Laser Debridement Negative	0 Participants	2 Participants
Bacterial Load Pre- and Post-Laser Debridement <10^5 CFU/g	6 Participants	11 Participants
Bacterial Load Pre- and Post-Laser Debridement >=10^5 CFU/g	16 Participants	9 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Laser Debridement n=22 Participants Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.	Sharp Debridement n=22 Participants Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
Bacterial Load Pre- and Post-Sharp Debridement <10^5 CFU/g	12 Participants	10 Participants
Bacterial Load Pre- and Post-Sharp Debridement >=10^5 CFU/g	10 Participants	7 Participants
Bacterial Load Pre- and Post-Sharp Debridement Negative	0 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Survey respondents were included in the analysis.

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

Outcome measures

Outcome measures
Measure	Laser Debridement n=17 Participants Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.	Sharp Debridement Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
Patient Preference Prefer laser	9 Participants	—
Patient Preference Prefer sharp	6 Participants	—
Patient Preference Unsure	2 Participants	—

SECONDARY outcome

Timeframe: Day 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.

Outcome measures

Outcome measures
Measure	Laser Debridement n=22 Participants Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.	Sharp Debridement n=22 Participants Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
Percent Change in Wound Size- Immediately Post-debridement	40.2 percent change Standard Deviation 95.0	63.4 percent change Standard Deviation 96.8

SECONDARY outcome

Timeframe: 1 week following respective procedure

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).

Outcome measures

Outcome measures
Measure	Laser Debridement n=22 Participants Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.	Sharp Debridement n=22 Participants Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
Percent Change in Wound Size - 1 Week Post-debridement	-20.8 percent change Standard Deviation 80.1	-36.7 percent change Standard Deviation 54.3

Adverse Events

Laser Debridement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sharp Debridement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Geoffrey C. Gurtner, MD

Stanford University

Phone: 650-736-2776

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place