Trial Title:
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
NCT ID:
NCT05944913
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
STS
Negative Pressure Wound Therapy
Surgery with preoperative irradiation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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).
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Prevena
Description:
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.
Arm group label:
Arm A : Surgery for STS and prevena
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
CRENN Vincent, MD,surger
Phone:
0240083761
Phone ext:
+33
Email:
vincent.crenn@chu-nantes.fr
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
GOUIN François, MD, surger
Phone:
0469855311
Phone ext:
+33
Email:
francois.gouin@lyon.unicancer.fr
Contact backup:
Last name:
VAZ Gualter, MD, Surger
Phone:
0469855310
Phone ext:
+33
Email:
gualter.vaz@lyon.unicancer.fr
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
MICHOT Audrey, MD,surger
Phone:
0556333216
Email:
a.michot@bordeaux.unicancer.fr
Facility:
Name:
CHRU Tours Hôpital Trousseau
Address:
City:
Chambray-lès-Tours
Zip:
37170
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
LE NAIL Louis-Romée, MD,surger
Email:
lr.lenail@chu-tours.fr
Facility:
Name:
Centre Jean Perrin
Address:
City:
Clermont-Ferrand
Zip:
63011
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
GIMBERGUES Pierre, MD,surger
Phone:
0473278000
Email:
pierre.gimbergues@clermont.unicancer.fr
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
CAUSERET Sylvain, MD, surger
Email:
scauseret@cgfl.fr
Facility:
Name:
Centre Oscar Lambert
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
DECANTER Gauthier, MD,surger
Email:
g-decanter@o-lambret.fr
Facility:
Name:
CHU Limoges
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
FIORENZA Fabrice, MD,surger
Email:
fabrice.fiorenza@chu-limoges.fr
Facility:
Name:
Institut du Cancer de Montpellier
Address:
City:
Montpellier
Zip:
34090
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
CARRERE Sébastien, MD,surger
Phone:
0467614539
Email:
sebastien.carrere@icm.unicancer.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
TZANIS Dimitri, MD, surger
Email:
dimitri.tzanis@curie.fr
Facility:
Name:
APHP Hôpital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
BIAU David, MD,surger
Email:
david.biau@aphp.fr
Facility:
Name:
CHU Rennes
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
ROPARS Mickaël, MD,surger
Email:
mickael.ropars@chu-rennes.fr
Facility:
Name:
IUCT Oncopole
Address:
City:
Toulouse
Zip:
31100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
MERESSE Thomas, MD,surger
Phone:
0531156032
Email:
meresse.thomas@iuct-oncopole.fr
Start date:
August 3, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Centre Leon Berard
Agency class:
Other
Source:
Centre Leon Berard
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05944913
