An observational study in Sarcoma, Soft Tissue, sponsored by The Cleveland Clinic. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by The Cleveland Clinic · Observational
Wound complications after sarcoma resection are frequent and potentially devastating problem. The burden of surgical wound complications in the lower extremity after preoperative external beam radiation therapy (EBRT) for soft tissue sarcoma is estimated at 43%. A noninvasive method of predicting complications would be extremely beneficial. The aim of this study is to evaluate the relationship between preoperative skin oxygenation and wound outcomes in a multi-center prospective analysis. This information could lead to a change in practice regarding surgical timing and adjunctive interventions to improve wound healing outcomes.
It is estimated that there are 11,400 new cases of soft tissue sarcoma diagnosed in the United States annually. Most high-grade sarcomas, and other selected low or intermediate grade sarcomas, are treated with a limb salvage surgical resection in conjunction with external beam radiation to optimize local control. The current preference of most practicing orthopaedic/surgical oncologists and radiation oncologists is to implement the radiation treatments prior to surgery to diminish the total radiation dose and field size, thereby optimizing long-term functional results of the salvaged limb. While there are clear advantages of preoperative radiation, there are well-demonstrated negative consequences with regard to healing of the surgical wound. Currently there are no reliable clinical criteria to aid physicians in determining an individual patient's risk of developing a postoperative wound complication. This fact, combined with the rarity of the sarcoma diagnosis, has prevented improvement in wound outcomes in sarcoma patients.
This project is designed to close this critical gap in knowledge. The investigators propose utilizing a preoperative measurement of transcutaneous oxygen (Tc02) at the proposed incision to classify patients into high- and low-risk categories for development of wound complications after resection. Measurement of preoperative TcO2 represents a novel application of a simple, noninvasive method by which to assess skin oxygenation. Given the results of an already completed pilot investigation (Nystrom 2016), the investigators believe that this important clinical problem is well suited for a prospective, multi-disciplinary, multi-institutional investigation.
A successful project would result in an enhanced ability to identify wounds at risk prior to surgery and allow for additional investigation into perioperative interventions (delay of surgery until recovery of oxygenation, increasing suture duration, judicious use of muscle flaps and skin grafts, postoperative hyperbaric oxygen, or treatment with incisional wound vacuum-assisted closure) that may mitigate this significant adverse outcome.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 39 is below the median of 121 across 238 observational studies indexed under Sarcoma.
Browse Sarcoma studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
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Adult patients with soft tissue sarcoma of the lower extremity with plan for treatment by preoperative radiation followed by limb sparing surgical resection.
Exclusion Criteria:
The transcutaneous oxygen at your surgical site will be measured at three time points prior to your surgery.
Wound healing
Your wound will be assessed clinically for evidence of healing or any wound complication (ie. infection, dehiscence, seroma).
Time frame: 120 days
Plan to share: Yes
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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