Clinical trial · Interventional
Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing
Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing: a Randomised Phase II Trial
NCT07048184CI-TRIAL-00091939SUNDIALnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To compare the differences in clinical outcomes and health economics between standard absorbent dressings versus Negative Pressure Wound Therapy dressings following the surgical resection of sarcoma tumours.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Negative Pressure Therapy | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) Dressings | Device | — | UNRESOLVED |
| Standard Absorbent Dressings | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Absorbent Dressing
- description
- Standard Absorbent Dressings for wound closure
- interventionNames
- Device: Standard Absorbent Dressings
- type
- EXPERIMENTAL
- label
- Negative Pressure Wound Therapy Dressing
- description
- NPWT Dressings will be used for wound closure
- interventionNames
- Device: Negative Pressure Wound Therapy (NPWT) Dressings
Primary outcomes (2)
- measure
- Clinical Outcome: The proportion of patients experiencing wound complications
- timeFrame
- From surgery to 4 months post-op
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Sarcoma of the upper/lower limb or torso requiring wide local excision, planned marginal excision or amputation * Able to provide informed consent * Aged 16 years or over * Able, and willing, to adhere to scheduled trial procedures and visit schedule Exclusion Criteria: * Previous surgery to planned surgical field * Contra-indication to surgical excision of the tumour * Disseminated malignancy on pre-op radiological imaging * Post-radiation sarcoma * Allergy to adhesive dressing * Subjects who, in the opinion of the PI, will be unable to comply with follow-up
References
Publications (6)
- BACKGROUNDSemsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519. PMID 26313829
- BACKGROUNDBedi M, King DM, DeVries J, Hackbarth DA, Neilson JC. Does Vacuum-assisted Closure Reduce the Risk of Wound Complications in Patients With Lower Extremity Sarcomas Treated With Preoperative Radiation? Clin Orthop Relat Res. 2019 Apr;477(4):768-774. doi: 10.1097/CORR.0000000000000371. PMID 30811365
- BACKGROUNDOuyang Z, Trent S, McCarthy C, Cosker T, Stuart R, Pratap S, Whitwell D, White HB, Tao H, Guo X, Maxime Gibbons CL. The incidence, risk factors and outcomes of wound complications after preoperative radiotherapy and surgery for high grade extremity soft tissue sarcomas: A 14-year retrospective study. Eur J Surg Oncol. 2023 Nov;49(11):107086. doi: 10.1016/j.ejso.2023.107086. Epub 2023 Sep 16. PMID 37741042
- 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
- BACKGROUNDShields DW, Razii N, Doonan J, Mahendra A, Gupta S. Closed incision negative pressure wound therapy versus conventional dressings following soft-tissue sarcoma excision: a prospective, randomized controlled trial. Bone Jt Open. 2021 Dec;2(12):1049-1056. doi: 10.1302/2633-1462.212.BJO-2021-0103.R1. PMID 34905941
- BACKGROUNDNandra R, Hwang N, Matharu GS, Reddy K, Grimer R. One-year mortality in patients with bone and soft tissue sarcomas as an indicator of delay in presentation. Ann R Coll Surg Engl. 2015 Sep;97(6):425-33. doi: 10.1308/003588415X14181254790284. Epub 2015 Aug 14.