Trial Outcomes & Findings for EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds (NCT NCT03960463)

Last Updated: 2025-01-23

Results Overview

Unfavorable wound healing outcomes were defined as the occurrence of one or more of the following conditions : infection, wound dehiscence, or necrotic tissue, as documented in the patient chart up to 4 weeks after the surgical wound closure.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Active Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Overall Study STARTED	22	11
Overall Study COMPLETED	20	11
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Active n=20 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=11 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks	8 Participants	7 Participants

SECONDARY outcome

Timeframe: baseline and week 4

Population: Subjects with wound adhesive issues (e.g., wound re-opening) were excluded, and those with unavailable wound data at 4 weeks were not included

Length of surgical closed wound was measured using camera . The unit is cm

Outcome measures

Outcome measures
Measure	Active n=13 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=8 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Length of Wound Baseline	4.78 cm Standard Deviation 3.36	4.28 cm Standard Deviation 3.11
Length of Wound week 4	3.57 cm Standard Deviation 2.92	7.28 cm Standard Deviation 2.92

SECONDARY outcome

Timeframe: baseline to 4 weeks

Population: The data for some participants were not available

skin perfusion will be assessed Skin Perfusion Pressure Test (SPP)

Outcome measures

Outcome measures
Measure	Active n=14 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=11 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Change in Skin Perfusion at Baseline and 4 Weeks Baseline	62.2 mm Hg Standard Deviation 18	72.3 mm Hg Standard Deviation 3.2
Change in Skin Perfusion at Baseline and 4 Weeks At 4 weeks	63.1 mm Hg Standard Deviation 20	63.2 mm Hg Standard Deviation 19.9

SECONDARY outcome

Timeframe: baseline to 4 weeks

Population: Only participants with available data at baseline and 4 weeks were included

Tissue oxygen saturation was assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)

Outcome measures

Outcome measures
Measure	Active n=14 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=11 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks Baseline	50 Percentage of tissue oxygen saturation Standard Deviation 19.9	56 Percentage of tissue oxygen saturation Standard Deviation 1.9
Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks 4 weeks	50.6 Percentage of tissue oxygen saturation Standard Deviation 14.3	50 Percentage of tissue oxygen saturation Standard Deviation 21

SECONDARY outcome

Timeframe: week 4

Population: Only participants with available data at week 4 were included

Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.

Outcome measures

Outcome measures
Measure	Active n=11 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=8 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Self-reported Pain at Week 4	2.09 units on a scale Standard Deviation 3.27	2.25 units on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: 4 weeks

Population: The data for one subject in the active group (out of the 20 subjects included) was unavailable.

The need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure.

Outcome measures

Outcome measures
Measure	Active n=19 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=11 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Reintervention	2 Participants	2 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active n=20 participants at risk Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=11 participants at risk Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
General disorders Non-Study Related Adverse Event	10.0% 2/20 • AEs were collected from study start date to the study completion date in a non-systematic way. Per patient, AEs were collected up to 4 weeks after baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred. The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.	0.00% 0/11 • AEs were collected from study start date to the study completion date in a non-systematic way. Per patient, AEs were collected up to 4 weeks after baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred. The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.

Additional Information

Bijan Najafi

Baylor College of Medicine

Phone: 7137987536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active n=20 Participants Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care. Transcu O2®: Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.	Control n=11 Participants Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.	Total n=31 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 10.6 • n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	64.6 years STANDARD_DEVIATION 9.1 • n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	64.5 years STANDARD_DEVIATION 9.9 • n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Sex: Female, Male Female	11 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	2 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	13 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Sex: Female, Male Male	9 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	9 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	18 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) Asian	1 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	1 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) Black or African American	7 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	3 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	10 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) White	8 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	6 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	14 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) More than one race	1 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	1 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=20 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	2 Participants n=11 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	5 Participants n=31 Participants • We initially enrolled 33 participants (Active:22, Control:11). Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Region of Enrollment United States	20 Participants n=20 Participants	11 Participants n=11 Participants	31 Participants n=31 Participants
CKD (Chronic Kidney Disease)	10 Participants n=18 Participants • Diagnosis of CKD was unknown for two of participants out of 20	4 Participants n=11 Participants • Diagnosis of CKD was unknown for two of participants out of 20	14 Participants n=29 Participants • Diagnosis of CKD was unknown for two of participants out of 20
HbA1c	9.4 % HbA1c STANDARD_DEVIATION 3.5 • n=20 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	7.2 % HbA1c STANDARD_DEVIATION .8 • n=11 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	8.6 % HbA1c STANDARD_DEVIATION 3.0 • n=31 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Type of Surgery Toe amputations	17 Participants n=20 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	11 Participants n=11 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	28 Participants n=31 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Type of Surgery Transmetatarsal amputation	1 Participants n=20 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=11 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	1 Participants n=31 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.
Type of Surgery Revision of amputation site	2 Participants n=20 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	0 Participants n=11 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.	2 Participants n=31 Participants • Two subjects in the active group withdrew consent after recruitment and prior to receiving the intervention. As a result, data from 20 participants in the active group were reported.