Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds

Study Overview
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Brief Summary
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We have designed this study to determine whether performing two, compared with ≥3 operations has an effect on key clinical outcomes after discharge from the hospital of an infected wound that requires admission. Each arm of this study represents the two commonly practiced standard of care treatment plans for patients presenting with infected wounds. It is currently unknown which SoC option provides the best patient outcome.

Detailed Description
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There is a lack of consensus about whether or not a patient with an infected wound requires more than 2 surgical procedures. For patients admitted for an infected wound this study will investigate whether 2, compared with ≥3, operative interventions results in better outcomes. All patients admitted for an infected wound will be assessed for eligibility in the study. If eligible, subjects will be randomized into Cohort A (2 operative visits) or Cohort B (≥3 operative visits). Subjects will then be followed during the hospitalization as well as 180 days post discharge. A total of 250 subjects will be enrolled into this study. Two operations (n=125) will be compared with ≥3 operations (n=125) during the hospitalization. We will compare the following factors between the two treatment groups: length of hospital stay; readmission post-discharge; quality of life; proportion of wounds closed or covered with a graft; culture results; host factors; environmental factors post-hospital discharge; and, financial charges related to admission and readmission. We expect full enrollment to take 3 years in duration. Debridement of the wound will be performed in the customary manner per SOC in the operating room. Prior to the start of the study, the surgeons performing the operations will be required to view a video that demonstrates the standardized debridement technique that will be utilized. The following is the standardized technique depicted in the video: All wound surfaces will be painted with dye prior to debridement. Debridement involves the use of a scalpel, scissors, curette, rongeur, or hydro-surgery. A 2-3 millimeter skin edge around the perimeter of the wound will also be resected. All infected/nonviable tissue will be removed and all tissues with dye will be surgically removed. This includes decompression of any purulent material and excision of any indurated tissue (until tissue pliability is established). Nonviable tissue includes necrotic and fibrous tissue. Debridement will be performed until the there is bleeding on the wound base and perimeter.

Official Title
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A Randomized Trial Comparing the Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds Requiring Hospitalization

Conditions
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Wound Infection

Intervention / Treatment
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* Procedure: Debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infected wound requiring hospital admission Infected wound requiring an operative intervention Wound can be located anywhere on the body Patient able and willing to comply with all study requirements Exclusion Criteria: Planned free tissue flap for soft tissue reconstruction Wound located over exposed joint implant Wound located over exposed hardware Disease or treatment causing substantial immunosuppression History of collagen vascular disease Transplant recipient Venous stasis ulcer Radiation-induced ulcer Contraindication for use of negative pressure wound therapy with instillation of normal saline Unable or unwilling to comply with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 operations<br>Subjects in this arm will receive a maximum of two surgical debridements of their wound. | Procedure: Debridement<br>* Removing dead tissue from infected wounds.<br>|
| Active Comparator: 3 or more operations<br>Subjects in this arm will receive three or more surgical debridements of their wound. | Procedure: Debridement<br>* Removing dead tissue from infected wounds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure. |  | 180 Days |