NCT02897128

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

4.3 years

First QC Date

September 7, 2016

Last Update Submit

July 19, 2021

Conditions

Sarcoma, Soft Tissue

Keywords

SarcomaRadiationWound healing

Outcome Measures

Primary Outcomes (1)

  • Wound healing

    Your wound will be assessed clinically for evidence of healing or any wound complication (ie. infection, dehiscence, seroma).

    120 days

Interventions

Observational Only - Transcutaneous Oxygen MeasurementOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with soft tissue sarcoma of the lower extremity with plan for treatment by preoperative radiation followed by limb sparing surgical resection.

You may qualify if:

  • age \> 18
  • biopsy proven soft tissue sarcoma of the lower extremity (pelvic area and below)
  • plan for preoperative radiation and limb sparing resection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

  • 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. doi: 10.1016/S0140-6736(02)09292-9.

    PMID: 12103287BACKGROUND

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

    PMID: 27528847RESULT

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Lukas M Nystrom, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 13, 2016

Study Start

July 1, 2016

Primary Completion

September 30, 2020

Study Completion

January 15, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Locations

US(4)