Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy (TPN-RAD)
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| ClinicalTrials.gov Identifier: NCT05944913 |
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Recruitment Status :
Recruiting
First Posted : July 13, 2023
Last Update Posted : September 5, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Soft Tissue Sarcoma | Device: Prevena | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 166 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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). |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | August 3, 2023 |
| Estimated Primary Completion Date : | August 2025 |
| Estimated Study Completion Date : | August 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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) |
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. |
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No Intervention: 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. |
- The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS [ Time Frame: At 3 months post-surgery visit ]Assessed by major wound complications rate
- Three month deep infection rate [ Time Frame: At 3 months post-surgery visit ]Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months
- Three months secondary surgery for wound healing problem rate [ Time Frame: At 3 months post-surgery visit ]Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months
- Hospitalization duration [ Time Frame: At 3 months post-surgery visit ]Defined as the number of hospitalization days from the date of surgery to the date of discharge
- Time to complete wound healing [ Time Frame: Up to 27 months ]Defined as the interval from surgery to 100% healing (total wound closure with no need for dressing and any local care)
- Number and types of major wound complications (MWCs) [ Time Frame: Up to 27 months ]Assessed by a number and differens types of a major wound complications
- Quality of life using EQ-5D-5L [ Time Frame: At 28 days and 3 months after surgery for each patients ]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.
- Incidence of Adverse Events [ Time Frame: Up to 27months ]Defined by the number of patients with Adverse Events (any type and any grade using the NCI-CTC AE scale version 5.0)
- Quality of life using FACT-G [ Time Frame: At 28 days and 3 months after surgery for each patients ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944913
| Contact: François Gouin, MD, Chirurgien | 0469855311 ext +33 | Francois.GOUIN@lyon.unicancer.fr | |
| Contact: Séverine METZGER, Project Manager | 0478782786 ext +33 | severine.metzger@lyon.unicancer.fr |
| France | |
| CHU Nantes | Not yet recruiting |
| Nantes, Pays De Loire, France, 44093 | |
| Contact: CRENN Vincent, MD,surger 0240083761 ext +33 vincent.crenn@chu-nantes.fr | |
| Centre Leon Berard | Recruiting |
| Lyon, Rhône-Alpes Auvergne, France, 69008 | |
| Contact: GOUIN François, MD, surger 0469855311 ext +33 francois.gouin@lyon.unicancer.fr | |
| Contact: VAZ Gualter, MD, Surger 0469855310 ext +33 gualter.vaz@lyon.unicancer.fr | |
| Institut Bergonié | Not yet recruiting |
| Bordeaux, France, 33076 | |
| Contact: MICHOT Audrey, MD,surger 0556333216 a.michot@bordeaux.unicancer.fr | |
| CHRU Tours Hôpital Trousseau | Not yet recruiting |
| Chambray-lès-Tours, France, 37170 | |
| Contact: LE NAIL Louis-Romée, MD,surger lr.lenail@chu-tours.fr | |
| Centre Jean Perrin | Not yet recruiting |
| Clermont-Ferrand, France, 63011 | |
| Contact: GIMBERGUES Pierre, MD,surger 0473278000 pierre.gimbergues@clermont.unicancer.fr | |
| Centre Georges François Leclerc | Not yet recruiting |
| Dijon, France, 21000 | |
| Contact: CAUSERET Sylvain, MD, surger scauseret@cgfl.fr | |
| Centre Oscar Lambert | Not yet recruiting |
| Lille, France, 59000 | |
| Contact: DECANTER Gauthier, MD,surger g-decanter@o-lambret.fr | |
| CHU Limoges | Not yet recruiting |
| Limoges, France, 87042 | |
| Contact: FIORENZA Fabrice, MD,surger fabrice.fiorenza@chu-limoges.fr | |
| Institut du Cancer de Montpellier | Not yet recruiting |
| Montpellier, France, 34090 | |
| Contact: CARRERE Sébastien, MD,surger 0467614539 sebastien.carrere@icm.unicancer.fr | |
| Institut Curie | Not yet recruiting |
| Paris, France, 75005 | |
| Contact: TZANIS Dimitri, MD, surger dimitri.tzanis@curie.fr | |
| APHP Hôpital Cochin | Not yet recruiting |
| Paris, France, 75014 | |
| Contact: BIAU David, MD,surger david.biau@aphp.fr | |
| CHU Rennes | Not yet recruiting |
| Rennes, France, 35033 | |
| Contact: ROPARS Mickaël, MD,surger mickael.ropars@chu-rennes.fr | |
| IUCT Oncopole | Not yet recruiting |
| Toulouse, France, 31100 | |
| Contact: MERESSE Thomas, MD,surger 0531156032 meresse.thomas@iuct-oncopole.fr | |
| Principal Investigator: | François Gouin, MD, Chirurgien | Centre Leon Berard |
| Responsible Party: | Centre Leon Berard |
| ClinicalTrials.gov Identifier: | NCT05944913 |
| Other Study ID Numbers: |
ET22-146 |
| First Posted: | July 13, 2023 Key Record Dates |
| Last Update Posted: | September 5, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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STS Negative Pressure Wound Therapy Surgery with preoperative irradiation |
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Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |