Clinical trial NCT05944913: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma
Keywords: STS
Negative Pressure Wound Therapy
Surgery with preoperative irradiation
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization (1:1 ratio) will be stratified according to STS location (upper limb vs lower limb vs trunk) and ASA class (1 or 2 vs ≥ 3).
Primary purpose: OTHER

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 criteria: Inclusion Criteria:

* Age ≥ 18 years at the day of consenting to the study
* 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:

* Known hypersensibility to silver
* Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor
* Planned no wound-closure and skin graft after resection
* Patient requiring authorship or curators or patient deprived of liberty.

Primary outcomes:
measure: The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
timeFrame: At 3 months post-surgery visit
Secondary outcomes:
measure: Three month deep infection rate
timeFrame: At 3 months post-surgery visit
measure: Three months secondary surgery for wound healing problem rate
timeFrame: At 3 months post-surgery visit
measure: Hospitalization duration
timeFrame: At 3 months post-surgery visit
measure: Time to complete wound healing
timeFrame: Up to 27 months
measure: Number and types of major wound complications (MWCs)
timeFrame: Up to 27 months
measure: Quality of life using EQ-5D-5L
timeFrame: At 28 days and 3 months after surgery for each patients
measure: Incidence of Adverse Events
timeFrame: Up to 27months
measure: Quality of life using FACT-G
timeFrame: At 28 days and 3 months after surgery for each patients
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
state: Pays De Loire
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes Auvergne
city: Bordeaux
country: France
facility: Institut Bergonié
city: Chambray-lès-Tours
country: France
facility: CHRU Tours Hôpital Trousseau
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambert
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Rennes
country: France
facility: CHU Rennes
city: Toulouse
country: France
facility: IUCT Oncopole
Study officials:
affiliation: Centre Leon Berard
name: François Gouin, MD, Chirurgien
role: PRINCIPAL_INVESTIGATOR
References: