Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization
Objective: Patients undergoing vascular surgery are at increased risk of poor wound healing due to ischemia and their underlying comorbidities. Following lower extremity revascularization, 40% to 50% of patients experience non-healing wounds that persist for months despite functional bypass grafts....
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-01-01
|
| Series: | JVS-Vascular Insights |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949912725000534 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850260585475735552 |
|---|---|
| author | Khanjan Nagarsheth, MD Georges Jreij, MD Eleanor Dunlap, DNP Shannon Hawkins, DNP Rachel White, BSN Areck Ucuzian, MD, PhD Brajesh K. Lal, MD |
| author_facet | Khanjan Nagarsheth, MD Georges Jreij, MD Eleanor Dunlap, DNP Shannon Hawkins, DNP Rachel White, BSN Areck Ucuzian, MD, PhD Brajesh K. Lal, MD |
| author_sort | Khanjan Nagarsheth, MD |
| collection | DOAJ |
| description | Objective: Patients undergoing vascular surgery are at increased risk of poor wound healing due to ischemia and their underlying comorbidities. Following lower extremity revascularization, 40% to 50% of patients experience non-healing wounds that persist for months despite functional bypass grafts. Additionally, surgical site infections (SSIs) in these patients can lead to sepsis, disability, and limb loss. SSI rates are reported between 5% and 10% and as high as 32% for infrainguinal incisions. Supplemental systemic oxygen therapy has shown promise in improving wound healing and reducing SSIs. An emerging alternative is transdermal continuous oxygen therapy (TCOT), which delivers oxygen directly to the wound, thereby avoiding systemic effects of oxygen and simplifying the logistics of oxygen delivery. TCOT has demonstrated faster wound healing and lower infection rates compared with standard of care wound therapy in preliminary studies. We propose a randomized trial to provide level one evidence on the effectiveness of TCOT in improving incisional healing and reducing SSI rates in vascular surgery patients. Methods: This randomized controlled trial will enroll 100 participants aged 18 to 90 years undergoing elective lower extremity arterial revascularization at the University of Maryland Medical Center and Baltimore VA Medical Center. Participants will be randomized 1:1 to receive either TCOT with control dressing, or control dressing alone. The investigational device, EPIFLO, will be used to deliver continuous oxygen to the wound via a semi-occlusive dressing for up to 28 days. The primary endpoint is the percent wound closure rate at 4 weeks, assessed using the Bates-Jensen Wound Assessment Tool. The secondary endpoint is SSI incidence at 90 days, evaluated with the Szilagyi classification. Participants will attend five follow-up visits, during which wound healing, SSIs, and adverse events will be recorded. A centralized randomization system will ensure balanced allocation, and blinded evaluators will assess wound images to reduce bias. Statistical analysis will include mixed models for repeated measures and Barnard’s test for SSI rates. Conclusions: This study will provide level one evidence on the efficacy of TCOT in improving wound healing and preventing SSIs in vascular surgery patients. |
| format | Article |
| id | doaj-art-e9eb7d91f04944a69691a7360b2c1220 |
| institution | OA Journals |
| issn | 2949-9127 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JVS-Vascular Insights |
| spelling | doaj-art-e9eb7d91f04944a69691a7360b2c12202025-08-20T01:55:37ZengElsevierJVS-Vascular Insights2949-91272025-01-01310023610.1016/j.jvsvi.2025.100236Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularizationKhanjan Nagarsheth, MD0Georges Jreij, MD1Eleanor Dunlap, DNP2Shannon Hawkins, DNP3Rachel White, BSN4Areck Ucuzian, MD, PhD5Brajesh K. Lal, MD6Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDivision of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDivision of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDivision of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDivision of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDivision of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD; Vascular Service, Baltimore VA Medical Center, Baltimore, MDDivision of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD; Vascular Service, Baltimore VA Medical Center, Baltimore, MD; Correspondence: Brajesh K. Lal, MD, Professor of Surgery, University of Maryland, 22 South Green St, Baltimore, MD 21201Objective: Patients undergoing vascular surgery are at increased risk of poor wound healing due to ischemia and their underlying comorbidities. Following lower extremity revascularization, 40% to 50% of patients experience non-healing wounds that persist for months despite functional bypass grafts. Additionally, surgical site infections (SSIs) in these patients can lead to sepsis, disability, and limb loss. SSI rates are reported between 5% and 10% and as high as 32% for infrainguinal incisions. Supplemental systemic oxygen therapy has shown promise in improving wound healing and reducing SSIs. An emerging alternative is transdermal continuous oxygen therapy (TCOT), which delivers oxygen directly to the wound, thereby avoiding systemic effects of oxygen and simplifying the logistics of oxygen delivery. TCOT has demonstrated faster wound healing and lower infection rates compared with standard of care wound therapy in preliminary studies. We propose a randomized trial to provide level one evidence on the effectiveness of TCOT in improving incisional healing and reducing SSI rates in vascular surgery patients. Methods: This randomized controlled trial will enroll 100 participants aged 18 to 90 years undergoing elective lower extremity arterial revascularization at the University of Maryland Medical Center and Baltimore VA Medical Center. Participants will be randomized 1:1 to receive either TCOT with control dressing, or control dressing alone. The investigational device, EPIFLO, will be used to deliver continuous oxygen to the wound via a semi-occlusive dressing for up to 28 days. The primary endpoint is the percent wound closure rate at 4 weeks, assessed using the Bates-Jensen Wound Assessment Tool. The secondary endpoint is SSI incidence at 90 days, evaluated with the Szilagyi classification. Participants will attend five follow-up visits, during which wound healing, SSIs, and adverse events will be recorded. A centralized randomization system will ensure balanced allocation, and blinded evaluators will assess wound images to reduce bias. Statistical analysis will include mixed models for repeated measures and Barnard’s test for SSI rates. Conclusions: This study will provide level one evidence on the efficacy of TCOT in improving wound healing and preventing SSIs in vascular surgery patients.http://www.sciencedirect.com/science/article/pii/S2949912725000534Topical oxygen therapyTranscutaneous oxygen therapyWound careWound healing |
| spellingShingle | Khanjan Nagarsheth, MD Georges Jreij, MD Eleanor Dunlap, DNP Shannon Hawkins, DNP Rachel White, BSN Areck Ucuzian, MD, PhD Brajesh K. Lal, MD Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization JVS-Vascular Insights Topical oxygen therapy Transcutaneous oxygen therapy Wound care Wound healing |
| title | Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization |
| title_full | Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization |
| title_fullStr | Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization |
| title_full_unstemmed | Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization |
| title_short | Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization |
| title_sort | protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization |
| topic | Topical oxygen therapy Transcutaneous oxygen therapy Wound care Wound healing |
| url | http://www.sciencedirect.com/science/article/pii/S2949912725000534 |
| work_keys_str_mv | AT khanjannagarshethmd protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization AT georgesjreijmd protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization AT eleanordunlapdnp protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization AT shannonhawkinsdnp protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization AT rachelwhitebsn protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization AT areckucuzianmdphd protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization AT brajeshklalmd protocolforarandomizedcontrolledtrialoftransdermalcontinuousoxygentherapyforsurgicalsitewoundhealingafterlowerextremityrevascularization |