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financial reasons
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EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal Continuous Oxygen Therapy | Experimental | EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care |
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| Standard of care | No Intervention | standard wound care for 4 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiflo | Device | Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test. | The primary objective of this study is to assess surgical site infection within 30 days of surgery for "high risk" patients undergoing colo-rectal surgery in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control Measures as either yes infection or no infection | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of infection measured with the Southampton Scoring System | Severity of infection using Southampton Scoring System. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints | 30 days |
| Number of days until patients surgical site is healed |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Sarang Sarangapani, Ph.D. | Neogenix,LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
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Time to heal. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints |
| 30 days |
| Resource utilization - cost of treatments, hospital stays, bandages, nursing care | Resource utilization - cost of treatments, hospital stays, bandages, nursing care all measured in dollar amounts and then summed | 30 days |