Trial Outcomes & Findings for Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing (NCT NCT03644849)
NCT ID: NCT03644849
Last Updated: 2022-01-11
Results Overview
Number of participants with completely healed lower extremity wounds by the end of the study (week 12). Complete wound healing is defined by reepithelization of the wound.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
12 weeks (enrollment time per subject)
Results posted on
2022-01-11
Participant Flow
Participant milestones
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing
Baseline characteristics by cohort
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
n=24 Participants
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
n=24 Participants
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 12 • n=5 Participants
|
72 years
STANDARD_DEVIATION 12 • n=7 Participants
|
71 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (enrollment time per subject)Number of participants with completely healed lower extremity wounds by the end of the study (week 12). Complete wound healing is defined by reepithelization of the wound.
Outcome measures
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
n=23 Participants
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
n=21 Participants
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Number of Participants With Completely Healed Lower Extremity Wounds
|
20 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (enrollment time per subject)Number of participants who experienced adverse events at any time point throughout the study.
Outcome measures
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
n=23 Participants
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
n=21 Participants
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Number of Participants Who Experienced Adverse Events.
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeks (enrollment time per subject)Score on the EQ-5D-5L. This is a quality of life questionnaire where higher scores equate to a better quality of life. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
Outcome measures
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
n=23 Participants
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
n=21 Participants
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Quality of Life Measure EQ-5D-5L
|
90.7 scores on a scale
Standard Deviation 10.4
|
87.5 scores on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 12 weeks (enrollment time per subject)Wound temperature will be recorded in degrees Celsius through an infrared camera.
Outcome measures
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
n=23 Participants
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
n=21 Participants
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Wound Temperature Associated With Carbon Dioxide Ablative Fractional Laser for Healing Postoperative Lower Extremity Wounds.
|
32.41 degrees Celsius
Standard Deviation 2.51
|
31.76 degrees Celsius
Standard Deviation 1.98
|
Adverse Events
Fractional Carbon Dioxide Laser Intervention Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham Laser Intervention Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fractional Carbon Dioxide Laser Intervention Group
n=24 participants at risk
The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).
CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
|
Sham Laser Intervention Group
n=24 participants at risk
Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
16.7%
4/24 • Number of events 4 • Adverse events data was collected during the entire duration of the patient's enrollment in the study, which was until 12 weeks.
Infection was diagnosed with a positive culture.
|
8.3%
2/24 • Number of events 2 • Adverse events data was collected during the entire duration of the patient's enrollment in the study, which was until 12 weeks.
Infection was diagnosed with a positive culture.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place