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

Soft Tissue Sarcoma Clinical Trial

— TPN-RAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944913
• Other study ID #: ET22-146
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: Centre Leon Berard
• Contact: François Gouin, MD, Chirurgien
• Phone: 0469855311
• Email: Francois.GOUIN[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
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	Centre Leon Berard	Lyon	Rhône-Alpes Auvergne
France	Institut du Cancer de Montpellier	Montpellier
France	CHU Nantes	Nantes	Pays De Loire
France	APHP Hôpital Cochin	Paris
France	Institut Curie	Paris
France	CHU Rennes	Rennes
France	IUCT Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS	Assessed by major wound complications rate	At 3 months post-surgery visit
Secondary	Three month deep infection rate	Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months	At 3 months post-surgery visit
Secondary	Three months secondary surgery for wound healing problem rate	Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months	At 3 months post-surgery visit
Secondary	Hospitalization duration	Defined as the number of hospitalization days from the date of surgery to the date of discharge	At 3 months post-surgery visit
Secondary	Time to complete wound healing	Defined as the interval from surgery to 100% healing (total wound closure with no need for dressing and any local care)	Up to 27 months
Secondary	Number and types of major wound complications (MWCs)	Assessed by a number and differens types of a major wound complications	Up to 27 months
Secondary	Quality of life using EQ-5D-5L	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.	At 28 days and 3 months after surgery for each patients
Secondary	Incidence of Adverse Events	Defined by the number of patients with Adverse Events (any type and any grade using the NCI-CTC AE scale version 5.0)	Up to 27months
Secondary	Quality of life using FACT-G	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.	At 28 days and 3 months after surgery for each patients