Wounds and Injuries

All Conditions

Neoplasms

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Sarcoma

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

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)

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.

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.

Prevena

François Gouin, MD, Chirurgien

Séverine METZGER, Project Manager

CRENN Vincent, MD,surger

GOUIN François, MD, surger

VAZ Gualter, MD, Surger

MICHOT Audrey, MD,surger

LE NAIL Louis-Romée, MD,surger

GIMBERGUES Pierre, MD,surger

CAUSERET Sylvain, MD, surger

DECANTER Gauthier, MD,surger

FIORENZA Fabrice, MD,surger

CARRERE Sébastien, MD,surger

TZANIS Dimitri, MD, surger

BIAU David, MD,surger

ROPARS Mickaël, MD,surger

MERESSE Thomas, MD,surger

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)

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.

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).

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

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

Assessed by major wound complications rate

Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months

Defined as the number of hospitalization days from the date of surgery to the date of discharge

Defined as the interval from surgery to 100% healing (total wound closure with no need for dressing and any local care)

Assessed by a number and differens types of a major wound complications

Assessed by EQ-5D-5L introduce by EuroQol Group in 2009 with five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. A minimum value is 0 and a maximum value is 100. A mean worst value is 0 and a better mean value is 100.

Defined by the number of patients with Adverse Events (any type and any grade using the NCI-CTC AE scale version 5.0)

Assessed by FACT-G : Functionnal Assesment of Cancer Therapy with 27 items. There are four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. A minimum value is 0 and a maximum value is 4. A mean worst value is 0 and a better mean value is 108.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy	NCT05944913	Soft Tissue Sar...	Prevena	18 Years -	Centre Leon Berard
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy	NCT05944913	Soft Tissue Sar...	Prevena	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for surgery with preoperative irradiation