Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
NCT ID: NCT05944913
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
166 participants
INTERVENTIONAL
2023-08-03
2026-11-30
Brief Summary
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Detailed Description
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Both have similar local control efficacy, but preoperative RT results in lower rates of long-term fibrosis and lymphedema and improved joint mobility than postoperative RT. On the other hand, the adverse effect of pre-operative RT is a higher rate of wound post-operative complications and re-operations.
Any effort to reduce the high rate of postoperative complications could offer the advantage of preoperative RT in terms of reduced long-term sequelae compared with postoperative RT without a higher wound complication rate postoperatively. Short retrospective series of Negative Pressure Wound Therapy (NPWT) after surgical resection of Soft Tissue Sarcoma (STS) have reported very encouraging results in preventing wound complications: patients treated with NPWT were less likely to develop wound complications than those who did not receive it. Both groups did not report an increased rate of local recurrence. The use of NPWT would also reduce the cost of care by avoiding complications.
That's why the investigators propose this study comparing the use of a negative pressure dressing to a conventional dressing in patients with STS of the limbs or trunk resected after neo-adjuvant external radiotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Arm A : Surgery for STS and prevena
The surgery for the STS lesion will be performed according to standard practices.
PREVENA™ Incision Management System should be applied immediately post-surgery to clean surgically closed wounds. It should be continuously applied for a minimum of 2 days and up to a maximum of 7 days (as per PREVENA user manual)
Prevena
PREVENA™ is a CE-marked class IIa medical device. The PREVENA™ Incision Management System is also intended to manage the environment of closed surgical incisions and surround intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision.
Arm B : Surgery for STS and standard postoperative wound management
The surgery for the STS lesion will be performed according to standard practices.
The dressing and drainage of the wound will be performed according to usual practices, with the exception of negative pressure dressings.
No interventions assigned to this group
Interventions
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Prevena
PREVENA™ is a CE-marked class IIa medical device. The PREVENA™ Incision Management System is also intended to manage the environment of closed surgical incisions and surround intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision.
Eligibility Criteria
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Inclusion Criteria
* Patients with primary STS of the limb or trunk treated with preoperative external radiation therapy (decided in multidisciplinary board)
* Intent to cure resection required for STS planned between 3 to 8 weeks after the end of RT
* Planned primary wound closure, including local or distant jambeau
* Ability to understand and willingness for follow-up visits
* Covered by a medical insurance
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
Exclusion Criteria
* Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor. Nota bene: Only patients with bone tumors are affected; patients with soft tissue tumors can be included in the study.
* Patient in relapse setting;
* Patient requiring a surgical revision after R1 or R2 resection;
* Planned blade drainage;
* Planned no wound-closure and skin graft after resection
* Patient requiring authorship or curators or patient deprived of liberty.
18 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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François Gouin, MD, Chirurgien
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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CHU Nantes
Nantes, Pays de Loire, France
Centre Leon Berard
Lyon, Rhône-Alpes Auvergne, France
Institut de Cancérologie de l'Ouest - Pays de Loire
Angers, , France
Institut Bergonié
Bordeaux, , France
CHRU Tours Hôpital Trousseau
Chambray-lès-Tours, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambert
Lille, , France
CHU Limoges
Limoges, , France
Institut du Cancer de Montpellier
Montpellier, , France
Institut Curie
Paris, , France
APHP Hôpital Cochin
Paris, , France
CHU Rennes
Rennes, , France
IUCT Oncopole
Toulouse, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ET22-146
Identifier Type: -
Identifier Source: org_study_id
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