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EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

Evaluation of Oxygen Delivery With TransCu O2 to Study Success Rate of Surgically Closed Wounds

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03960463
Enrollment
33
Registered
2019-05-23
Start date
2017-05-18
Completion date
2024-07-24
Last updated
2025-01-23

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

Conditions

Amputation Wound, Breast Cancer, Diabetes, Diabetic Foot, Incision Wound, Peripheral Arterial Disease, Surgical Wound

Keywords

Infection, Dehiscence, Necrotic tissue, Surgical Revision, Scar tissue, Wound Closure

Brief summary

The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds. The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.

Detailed description

Surgical wound (e.g., post minor amputation, reconstruction surgery, or surgical incision) complications such as infection, dehiscence, necrotic tissue, surgical revision, and poor cosmesis are unfortunately highly prevalent in patients undergoing surgical interventions. In most cases surgical wounds are managed with a simple island dressing, orthopaedic wool padding and a light retention bandage. It could be argued that such low cost, traditional dressings are adequate for most surgical wounds. However, some patients with poor tissue integrity often require modern wound care products that offer additional benefits, in particular among those with vascular and poor tissue oxygenation problem. Poor tissue oxygenation and poor skin perfusion could lead to surgical wound complications such as wound infection, tissue necrosis, phantom pain, trauma and untimely surgical revision as well as major amputation. In particular, the presence of non-viable, necrotic tissue (estimated to occur in 15-25% of cases) is significant as it can be responsible for delaying healing, prolonging the inflammatory response, mechanically obstructing contraction and impeding re-epithelialisation. It also provides a focus for wound infection and surgical revision. The problem associated with necrotic tissue is not limited to limb amputation and could be seen in other surgical closures leading to excessive scar formation. Many of these scars can be problematic, being aesthetically unpleasant and causing discomfort. Blood supply is a significant factor in wound healing, and an area of the skin with rich supply of vasculature is known to heal to finer scars. Several studies have demonstrated that mild hypoxia (lack of transcutaneous oxygen) is present in early scars, moderate hypoxia in proliferative scars, and severe hypoxia in regressive scars. Oxygen levels then return to normal in mature scars, which is consistent along with the dynamic change in microvessel density. Therefore level of transcutaneous oxygen could be a determinant factor in formation of excessive scar formation. Dressing materials are known to influence postoperative surgical wound healing and scar formation. A particular dressing that could promote wound hydration is key to ensure quick epithelialization and decrease excessive scar formation. The current standard of care in wound healing is to promote a moist wound environment by regular changing dressing and hydrate wound when needed. Some new advanced dressing and products have been also suggested with promising results in reducing excessive scar formation such as the use of silicone sheeting, hydrogel wound dressing, etc. In this study, the investigators hypothesize that using novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.

Interventions

Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

Sponsors

Electrochemical Oxygen Concepts, Inc.
CollaboratorINDUSTRY
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 18-85 years of age. Ability to provide informed consent. * Presence of a wound due to surgical intervention and closure. * Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the wound) and applicable dressing changes

Exclusion criteria

* Charcot Arthropathy Bilateral AK/BK amputation Active Drug/alcohol abuse (or history of drug/alcohol abuse in last 1 month) Dementia or impaired cognitive function Subjects with osteomyelitis or extreme gangrene. Excessive lymphedema Presence of active infection Subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks4 weeksUnfavorable 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.

Secondary

MeasureTime frameDescription
Length of Woundbaseline and week 4Length of surgical closed wound was measured using camera . The unit is cm
Change in Skin Perfusion at Baseline and 4 Weeksbaseline to 4 weeksskin perfusion will be assessed Skin Perfusion Pressure Test (SPP)
Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeksbaseline to 4 weeksTissue oxygen saturation was assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)
Self-reported Pain at Week 4week 4Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.
Reintervention4 weeksThe need for podiatric reintervention (e.g., wound reclosure due to wound adhesive failure) within 30 days of surgical wound closure.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
20
Control
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
11
Total31

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicActiveControlTotal
Age, Continuous64.4 years
STANDARD_DEVIATION 10.6
64.6 years
STANDARD_DEVIATION 9.1
64.5 years
STANDARD_DEVIATION 9.9
CKD (Chronic Kidney Disease)10 Participants4 Participants14 Participants
HbA1c9.4 % HbA1c
STANDARD_DEVIATION 3.5
7.2 % HbA1c
STANDARD_DEVIATION 0.8
8.6 % HbA1c
STANDARD_DEVIATION 3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
7 Participants3 Participants10 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Race (NIH/OMB)
White
8 Participants6 Participants14 Participants
Region of Enrollment
United States
20 Participants11 Participants31 Participants
Sex: Female, Male
Female
11 Participants2 Participants13 Participants
Sex: Female, Male
Male
9 Participants9 Participants18 Participants
Type of Surgery
Revision of amputation site
2 Participants0 Participants2 Participants
Type of Surgery
Toe amputations
17 Participants11 Participants28 Participants
Type of Surgery
Transmetatarsal amputation
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 11
other
Total, other adverse events
2 / 200 / 11
serious
Total, serious adverse events
0 / 200 / 11

Outcome results

Primary

Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks

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.

Time frame: 4 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ActiveNumber of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks8 Participants
ControlNumber of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks7 Participants
Secondary

Change in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks

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

Time frame: baseline to 4 weeks

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

ArmMeasureGroupValue (MEAN)Dispersion
ActiveChange in Percentage of Tissue Oxygen Saturation From Baseline to 4 WeeksBaseline50 Percentage of tissue oxygen saturationStandard Deviation 19.9
ActiveChange in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks4 weeks50.6 Percentage of tissue oxygen saturationStandard Deviation 14.3
ControlChange in Percentage of Tissue Oxygen Saturation From Baseline to 4 WeeksBaseline56 Percentage of tissue oxygen saturationStandard Deviation 1.9
ControlChange in Percentage of Tissue Oxygen Saturation From Baseline to 4 Weeks4 weeks50 Percentage of tissue oxygen saturationStandard Deviation 21
Secondary

Change in Skin Perfusion at Baseline and 4 Weeks

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

Time frame: baseline to 4 weeks

Population: The data for some participants were not available

ArmMeasureGroupValue (MEAN)Dispersion
ActiveChange in Skin Perfusion at Baseline and 4 WeeksBaseline62.2 mm HgStandard Deviation 18
ActiveChange in Skin Perfusion at Baseline and 4 WeeksAt 4 weeks63.1 mm HgStandard Deviation 20
ControlChange in Skin Perfusion at Baseline and 4 WeeksBaseline72.3 mm HgStandard Deviation 3.2
ControlChange in Skin Perfusion at Baseline and 4 WeeksAt 4 weeks63.2 mm HgStandard Deviation 19.9
Secondary

Length of Wound

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

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
ActiveLength of WoundBaseline4.78 cmStandard Deviation 3.36
ActiveLength of Woundweek 43.57 cmStandard Deviation 2.92
ControlLength of WoundBaseline4.28 cmStandard Deviation 3.11
ControlLength of Woundweek 47.28 cmStandard Deviation 2.92
Secondary

Reintervention

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

Time frame: 4 weeks

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ActiveReintervention2 Participants
ControlReintervention2 Participants
Secondary

Self-reported Pain at Week 4

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

Time frame: week 4

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

ArmMeasureValue (MEAN)Dispersion
ActiveSelf-reported Pain at Week 42.09 units on a scaleStandard Deviation 3.27
ControlSelf-reported Pain at Week 42.25 units on a scaleStandard Deviation 1.98

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