Clinical trial · Observational
Transcutaneous Oxygen as a Predictor of Wound Healing Complications in Preoperatively Radiated Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational Only - Transcutaneous Oxygen Measurement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Wound healing
- timeFrame
- 120 days
- description
- Your wound will be assessed clinically for evidence of healing or any wound complication (ie. infection, dehiscence, seroma).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDO'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 12103287
- RESULTNystrom LM, Miller BJ. Transcutaneous Oximetry May Predict Wound Healing Complications In Preoperatively Radiated Soft Tissue Sarcoma. Iowa Orthop J. 2016;36:117-22. PMID 27528847