An interventional study of Debridement in Wound Infection, sponsored by Georgetown University. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Georgetown University · Not applicable, Interventional, and Treatment
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.
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.
388 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 301 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →Georgetown University is the lead sponsor of 291 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Subjects in this arm will receive a maximum of two surgical debridements of their wound.
Procedure: Debridement
Subjects in this arm will receive three or more surgical debridements of their wound.
Procedure: Debridement
Removing dead tissue from infected wounds.
Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure.
Time frame: 180 Days
No study locations are listed for this record.
Plan to share: No — Data was not collected for use in future research and will not be shared.
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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