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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2021-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds

NCT02638298

Sarcoma Cancer Infectious Disease

COMPLETED NA

Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients

NCT00315822

Surgical Wound Infection

TERMINATED NA

Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

NCT01826942

Scar Prevention

TERMINATED NA

Effect of Externally Implantable Tissue Expansion Device on Scar Length

NCT00798798

Skin Lesion

WITHDRAWN NA

Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair

NCT02357628

Wounds and Injuries

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcoma, Soft Tissue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational Only - Transcutaneous Oxygen Measurement

The transcutaneous oxygen at your surgical site will be measured at three time points prior to your surgery.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No