A parallel-group randomized pilot trial at a single institution (Duke University) on the effect of postoperative hyperbaric oxygen therapy on wound healing in patients with soft tissue sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.. Participants will be allocated to either the treatment group (HBOT) or control (standard of care) by computer-generated randomization, stratified by tumor size (≤10cm and \>10cm). An unequal randomization of 2:1 will be utilized to provide experience prescribing HBOT to more patients.
Patients with a primary diagnosis of soft tissue sarcoma of the lower extremities undergoing treatment with neo-adjuvant radiation therapy and surgical resection will be screened for eligibility. All participants will receive pre-operative radiation treatment per standard of care and will undergo surgical excision as planned and performed by one of the surgical oncologists at our center. Participants randomized to the treatment group will be scheduled for 7-10 HBO treatments within 7-10 days of surgery. All participants will be scheduled for follow-up visits with their surgical oncologist at the following post-operative time points: 3, 6, 12, and 24-weeks (+/- 14 days). Follow up for the purposes of this study will continue up to 6 months from the time of surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
Duke University
Durham, North Carolina, United States
Recruitment rate
The proportion of eligible patients who enroll in this study, as indicated by the screening log.
Time frame: Screening
Hyperbaric Treatment Completion Rate
The proportion of prescribed hyperbaric oxygen treatments that are completed, which will be recorded in the appointment log.
Time frame: 24 weeks postoperatively
Wound Assessment Form Completion Rate
The number of completed Wound Assessment Forms per participant divided by the total number of follow-up visits per participant.
Time frame: 24 weeks postoperatively
Participant Assessment Form Completion Rate
Number of completed Participant Assessment Forms per participant divided by the number of total follow-up visits per participant.
Time frame: 24 weeks postoperatively
patient reported study strengths and weaknesses
The Patient Feedback Survey will be given to all participants at their final study-related visit in order to collect qualitative and quantitative data on patient reported study strengths and weaknesses.
Time frame: 24 weeks postoperatively
barriers to compliance with study procedures
The Patient Feedback Survey will be given to all participants at their final study-related visit in order to collect qualitative and quantitative data on patient reported barriers to compliance with study procedures
Time frame: 24 weeks postoperatively
Frequency of surgical site infections or periprosthetic infections
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the number of participants with ≥ 1 completed Wound Assessment Form documenting infection or treatment for infection around the wound area at any follow-up visit.
Time frame: 24 weeks postoperatively
frequency of wound complications that result in a secondary procedure
the number of participants with ≥ 1 completed Wound Assessment Form that documents reoperation or any other invasive procedure after primary resection with any wound complication as the indication for the procedure.
Time frame: 24 weeks postoperatively
Wound Severity
Variability in clinical evaluations of wound severity will be determined by the Bates-Jensen Wound Assessment score recorded in the Wound Assessment Form.
Time frame: 24 weeks postoperatively
Frequency of delayed wound healing
The frequency of delayed wound healing will be determined by the number of participants with of ≥ 1 completed Wound Assessment Form documenting ≥ 1 clinical indication of a wound complication at any follow-up visit.
Time frame: 24 weeks postoperatively
Variability in Patient Reported Quality of Life
Variability in patient reported outcome data pertaining to quality of life will be determined by the ESAS-SM score alone at baseline and by the ESAS-SM and WOUND-Q: Life Impact scores recorded in the Participant Assessment Form at all follow-up visits.
Time frame: 24 weeks postoperatively
Variability in Patient Reported Wound Assessments
Variability in patient reported outcome data pertaining to wound assessments will be determined by the WOUND-Q: Wound Characterization score recorded in the Participant Assessment Form at all follow-up visits.
Time frame: 24 weeks postoperatively