An observational study in Wounds and Injuries, sponsored by Georgetown University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Georgetown University · Observational
Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™
This is a study examining the use of Integra™ for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications. Wounds requiring operative application of Integra™ alone or Integra™ followed by a planned subsequent application of a STSG will be enrolled into this study.
The tolerance of Integra™ to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts, qualitative culture results, and bacterial and wound protease levels at the time of Integra™ alone application or Integra™ followed by STSG application.
Patients will then be followed until complete healing has occurred or until 16 weeks, whichever comes first.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 54 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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The study population will be anyone who is experiencing partial or full thickness wounds, pressure ulcers, venous and diabetic ulcers, burns, and traumatic wounds.
Exclusion Criteria:
Integra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone
Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.
Quantitative CFUs will be obtained by obtaining tissue from the wound at the time of debridement from otherwise discarded tissue. After tissue cultures are obtained and sent to a designated microbial lab for analysis. Tissue culture is to be obtained from the central aspect of the wound bed. These cultures will be processed and analyzed for research purposes. Qualitative cultures will be obtained as per SOC and sent to the local lab per customary fashion. Qualitative bacterial protease and human inflammation protease indications will be obtained by sampling and testing two separate wound fluid swabs on investigational devices; WOUNDCHEKTM Bacterial Status and WOUNDCHEKTM Protease Status. Bacterial Status detects enzymes that are present when bacteria have become pathogenic while Protease Status detects enzymes present when the wound is in a chronically inflamed state. The tests will be obtained from Woundchek Labs.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
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Georgetown University