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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02897128.
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationCleveland Clinic Foundation