Transcutaneous Oxygen as a Predictor of Wound Healing Complications in Preoperatively Radiated Soft Tissue Sarcoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:July 2016
End Date:June 30, 2019
Contact:Lukas M Nystrom, MD
Email:nystrol@ccf.org
Phone:216-445-7164

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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.

Inclusion Criteria:

- age > 18

- biopsy proven soft tissue sarcoma of the lower extremity (pelvic area and below)

- plan for preoperative radiation and limb sparing resection

Exclusion Criteria:

- upper extremity sarcoma

- recurrent soft tissue sarcoma

- prior surgery in the area of the sarcoma

- prior radiation in the area of the sarcoma

- need for immediate skin graft or flap for coverage

- pregnant patients

- patients unwilling to have surgery or radiation
We found this trial at
5
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-7164
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Andre Spiguel, MD
Phone: 352-273-7077
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lee R Leddy, MD
Phone: 843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Benjamin J Miller, MD
Phone: 319-384-5535
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Jeremy R White, MD
Phone: 405-271-2663
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Oklahoma City, OK
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