Trial Outcomes & Findings for Continuous Diffusion of Oxygen Treatment for Incision Wounds (NCT NCT04307355)
NCT ID: NCT04307355
Last Updated: 2025-02-06
Results Overview
Wound size will be traced and quantified using a wound imaging system (Snapshot, Kent Imaging)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-02-06
Participant Flow
Participants were recruited from Baylor College of Medicine's Plastic Surgery Department through surgeon referrals or chart reviews. Of the 23 participants who met the inclusion criteria and enrolled, 3 withdrew.
Surgeries were performed on both breasts, with the intervention randomized to either the left or right breast, while the contralateral side served as the control. In other words, each subject acted as their own control. This resulted in data from 40 breasts across 20 participants-20 control and 20 intervention.
Unit of analysis: Breasts
Participant milestones
| Measure |
Direct CDO (dCDO)
Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
|
Control
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
|
Silicon CDO (sCDO)
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silicon sheet.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13 13
|
23 23
|
10 10
|
|
Overall Study
COMPLETED
|
10 10
|
20 20
|
10 10
|
|
Overall Study
NOT COMPLETED
|
3 3
|
3 3
|
0 0
|
Reasons for withdrawal
| Measure |
Direct CDO (dCDO)
Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
|
Control
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
|
Silicon CDO (sCDO)
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silicon sheet.
|
|---|---|---|---|
|
Overall Study
Non-Compliance
|
3
|
3
|
0
|
Baseline Characteristics
Surgeries were performed on both breasts, with the intervention randomized to either the left or right breast, while the contralateral side served as the control for each intervention arm. Since each subject acted as their own control, there were no differences in age or other demographic factors between the control arms and the total cases.
Baseline characteristics by cohort
| Measure |
Direct CDO (dCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
|
Control
n=20 Breasts
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicone CDO (sCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using silicon sheet.
|
Total
n=40 Breasts
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.70 years
STANDARD_DEVIATION 6.02 • n=99 Participants • Surgeries were performed on both breasts, with the intervention randomized to either the left or right breast, while the contralateral side served as the control for each intervention arm. Since each subject acted as their own control, there were no differences in age or other demographic factors between the control arms and the total cases.
|
34.45 years
STANDARD_DEVIATION 10.56 • n=107 Participants • Surgeries were performed on both breasts, with the intervention randomized to either the left or right breast, while the contralateral side served as the control for each intervention arm. Since each subject acted as their own control, there were no differences in age or other demographic factors between the control arms and the total cases.
|
38.20 years
STANDARD_DEVIATION 13.34 • n=206 Participants • Surgeries were performed on both breasts, with the intervention randomized to either the left or right breast, while the contralateral side served as the control for each intervention arm. Since each subject acted as their own control, there were no differences in age or other demographic factors between the control arms and the total cases.
|
34.45 years
STANDARD_DEVIATION 10.33 • n=7 Participants • Surgeries were performed on both breasts, with the intervention randomized to either the left or right breast, while the contralateral side served as the control for each intervention arm. Since each subject acted as their own control, there were no differences in age or other demographic factors between the control arms and the total cases.
|
|
Sex/Gender, Customized
Female
|
10 participants
n=99 Participants
|
20 participants
n=107 Participants
|
10 participants
n=206 Participants
|
20 participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 participants
n=99 Participants
|
18 participants
n=107 Participants
|
9 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants • Only the participants who completed the study where included for analysis.
|
20 participants
n=107 Participants • Only the participants who completed the study where included for analysis.
|
10 participants
n=206 Participants • Only the participants who completed the study where included for analysis.
|
20 participants
n=7 Participants • Only the participants who completed the study where included for analysis.
|
|
Body Mass Index (BMI)
|
32.92 kg/m^2
STANDARD_DEVIATION 6.18 • n=99 Participants • Only the participants who completed the study where included for analysis.
|
34.27 kg/m^2
STANDARD_DEVIATION 5.29 • n=107 Participants • Only the participants who completed the study where included for analysis.
|
35.61 kg/m^2
STANDARD_DEVIATION 4.30 • n=206 Participants • Only the participants who completed the study where included for analysis.
|
34.27 kg/m^2
STANDARD_DEVIATION 5.29 • n=7 Participants • Only the participants who completed the study where included for analysis.
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Baseline participants are counted as individual breasts, with one breast treated with the intervention and the other with the standard of care. The study included 20 participants, resulting in 20 control breasts. Of the intervention breasts, 10 received dCDO and 10 received sCDO.
Wound size will be traced and quantified using a wound imaging system (Snapshot, Kent Imaging)
Outcome measures
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=20 Breasts
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Wound Size at 4 Weeks
|
1.5 cm^2
Standard Deviation 2.83
|
2.75 cm^2
Standard Deviation 7.2
|
0.15 cm^2
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Baseline participants are counted as individual breasts, with one breast treated with the intervention and the other with the standard of care. The study included 20 participants, resulting in 20 control breasts. Of the intervention breasts, 10 received dCDO and 10 received sCDO.
Complication is described as infection, dehiscence, and/or necrotic tissue
Outcome measures
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=20 Breasts
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Incidence of Wound Complication at 4 Weeks
|
1 Breasts
|
3 Breasts
|
0 Breasts
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Baseline participants are counted as individual breasts, with one breast treated with the intervention and the other with the standard of care. The study included 20 participants, resulting in 20 control breasts. Of the intervention breasts, 10 received dCDO and 10 received sCDO.
Scar tissue presence will be assessed by simple view.
Outcome measures
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=20 Breasts
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Presence of Scar Tissue
|
0 Breasts
|
0 Breasts
|
0 Breasts
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksDeoxyHb at the T-Junction of each breast will be assessed using near-infrared spectroscopy (Snapshot, Kent Imaging). DeoxyHb is measured as a fraction ranging from 0 to 1. The reported values below are the estimate percent change from the baseline visit to the 4th week visit.
Outcome measures
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=20 Breasts
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Change in DeoxyHB From Baseline to 4 Weeks
|
83.89 percentage change
Standard Error 15.89
|
136.07 percentage change
Standard Error 23.28
|
46.53 percentage change
Standard Error 25.698
|
SECONDARY outcome
Timeframe: At 4 weeksPopulation: The pain questionnaire was not asked until the sCDO group was added. Therefore, 0 samples from the dCDO group were analyzed.
Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever. At the final visit, patients were asked to rate their pain on this scale using the POSAS (Patient and Observer Scar Assessment Scale) questionnaire. An average of this score was taken across each group.
Outcome measures
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=6 Participants
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=9 Participants
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Self-reported Pain at Week 4
|
—
|
2.3 units on a scale
Standard Deviation 2.8
|
3.9 units on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Baseline participants are counted as individual breasts, with one breast treated with the intervention and the other with the standard of care. The study included 20 participants, resulting in 20 control breasts. Of the intervention breasts, 10 received dCDO and 10 received sCDO.
SatO2 at the T-Junction of each breast will be assessed using near-infrared spectroscopy (Snapshot, Kent Imaging). SatO2 is measured as a fraction ranging from 0 to 1. The reported values below are the estimate percent change from the baseline visit to the 4th week visit.
Outcome measures
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=20 Breasts
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=10 Breasts
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Change in Tissue Oxygen Saturation (SatO2) From Baseline to 4 Weeks
|
-33.57 percentage change
Standard Error 5.84
|
-23.30 percentage change
Standard Error 5.82
|
13.76 percentage change
Standard Error 12.12
|
Adverse Events
Direct Continuous Diffusion of Oxygen (dCDO)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Silicon Continuous Diffusion of Oxygen (sCDO)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Direct Continuous Diffusion of Oxygen (dCDO)
n=10 participants at risk
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Tegaderm adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Tegaderm: A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).
|
Control
n=20 participants at risk
One of the participant's breasts will receive a standard-of-care at the surgical site and will be followed for 4 weeks.
|
Silicon Continuous Diffusion of Oxygen (sCDO)
n=10 participants at risk
One of the participant's breasts will be provided with a Transcu O2 ® Oxygen delivery system and 4x4 dressing at the surgical site for 4 weeks as supportive care. The 4x4 dressing will be attached to breast using Silagen adhesive.
Transcu O2®: Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
Silagen: A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergy
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
0.00%
0/20 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
0.00%
0/10 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
|
Skin and subcutaneous tissue disorders
Skin irritation (Non-study related)
|
0.00%
0/10 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
|
Skin and subcutaneous tissue disorders
Itching, mild breakdown, and drainage
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
0.00%
0/10 • Adverse event data were collected throughout the study duration, up to 4 weeks for each participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place