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

Sarcoma, Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897128
• Other study ID #: 207638
• Status: Completed
• Start date: July 2016
• Est. completion date: January 15, 2021

Study information

• Verified date: July 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 15, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Other:
• Observational Only - Transcutaneous Oxygen Measurement
The transcutaneous oxygen at your surgical site will be measured at three time points prior to your surgery.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (6)

Lead Sponsor	Collaborator
The Cleveland Clinic	Musculoskeletal Tumor Society, Orthopedic Research and Education Foundation, University of Florida, University of Iowa, University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (2)

Nystrom LM, Miller BJ. Transcutaneous Oximetry May Predict Wound Healing Complications In Preoperatively Radiated Soft Tissue Sarcoma. Iowa Orthop J. 2016;36:117-22. — View Citation

O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Your wound will be assessed clinically for evidence of healing or any wound complication (ie. infection, dehiscence, seroma).	120 days