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Spots Global Cancer Trial Database for Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy

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Trial Identification

Brief Title: Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy

Official Title: Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy

Study ID: NCT05944913

Interventions

Prevena

Study Description

Brief Summary: This is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. The aim is to compare the efficacy of negative pressure therapy (PREVENA™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated Soft Tissue Sarcoma (STS)

Detailed Description: The gold standard treatment for primary non-metastatic STS is complete surgical resection. Peri-operative Radiation Therapy (RT) has been proved to improve local control . Nevertheless, the timing of RT, whether preoperative or postoperative, remains a debate. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU Nantes, Nantes, Pays De Loire, France

Centre Leon Berard, Lyon, Rhône-Alpes Auvergne, 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

Contact Details

Name: François Gouin, MD, Chirurgien

Affiliation: Centre Leon Berard

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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