INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients (VAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03175718|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft-tissue Sarcoma Wound Complication||Other: VAC Wound Dressing Other: Wound Dressing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||291 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a Canadian multicenter superiority randomized clinical trial in patients who are scheduled to undergo surgical resection of a soft tissue sarcoma treated with either preoperative or postoperative radiation therapy and a primary closure. The participants are randomized to two weeks of Incisional Negative Pressure Wound Therapy (Acelity) or conventional gauze dressing; the current standard of care.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||The operative team will remain blinded to the dressing until the time of application. This trial will not be blinded to any clinical staff involved due to logistical difficulties in blinding postoperative wound dressings involving a NPWT device. The Research Coordinator/Outcomes Assessor conducting the QoL and Functional Assessment components will be blinded to which arm the participant was in.|
|Official Title:||The Effect of INPWT on Wound Complications and Clinical Outcomes Following Lower Extremity Sarcoma Surgery in Patients Treated With Preoperative Radiation Therapy: A Multicentre Randomized Controlled Trial|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||February 29, 2020|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: VAC Wound Dressing
Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive 2 weeks of Incisional Negative pressure wound therapy.
Other: VAC Wound Dressing
A total of 291 patients will be randomized to receive 2 weeks of Incisional Negative pressure wound dressing (Acetily®). The sterile dressing will be applied under a continuous pressure of 125mmHg. The dressing will be changed every 2-3 days. For a total duration of 2 weeks.
Active Comparator: Control Wound Dressing
Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive 2 weeks of standard gauze dressing with no negative pressure application.
Other: Wound Dressing
A total of 291 patients will be randomized for standard gauze dressing. This dressing requires no pressure and is applied according to the current standard dressing procedures of the institution. The dressing will be changed every 2-3 days. For a total duration of 2 weeks.
- Wound Complication including re-operation for superficial or deep site infection [ Time Frame: 120 days post op ]
- Wound requiring deep wound packing to an area greater than 2cm in length
- Wound requiring persistent dressing changes for greater than 6 weeks. Wound packing and persistent requirement to change the dressing will reflect if the patient has a wound complication.
- Quality of Life [ Time Frame: All within this 120 day post-op ]Patient satisfaction will be evaluated by validated questionnaires.
- Functional outcome [ Time Frame: 120 days postop ]Secondary outcomes include length of stay in hospital,
- Overall cost [ Time Frame: 120 days ]A cost analysis will be performed by evaluating the average inpatient cost per day, number of emergency department and clinic visits, cost of secondary procedures cost of INPWT and cost of home care visits.
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): NCT03175718
|Contact: Yusra K Al Mosuli||6137378920 ext firstname.lastname@example.org|
|Contact: Johanna Dobransky||6137378920 ext email@example.com|
|Principal Investigator:||Joel Werier||Surgeon|