Cancer Clinical Trial
Official title:
Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall. A Randomized Controlled Trial
The purpose of this research project is to improve the surgical treatment of Soft Tissue Sarcoma (STS) treatment based upon a Randomized Controlled Trial (RCT). We want to evaluate the effect of the use of Negative Pressure Wound Therapy (NPWT) versus a conventional wound dressing on postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Surgery for a deep-seated STS of an extremity or the trunk wall at Rigshospitalet. Exclusion Criteria: - Age < 18 years - Wound closure not possible without plastic surgery (pedicled or free flaps) - Low malignant (Trojani grade 1) STS or borderline tumors - Pre- or postoperative chemotherapy - Preoperative radiotherapy to the local site. - Allergic or hypersensitive to acrylic adhesives or silver - Unwilling or unable to provide informed consent - Inability to comply with planned study procedures - Patients with metastatic disease. - Patients with ischemic surgery such as bypass or endovascular prosthesis |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound complication/healing | A major wound complication defined as in O'Sullivan et al. [11]:
A secondary surgery under anesthesia for wound repairs such as debridement, operative drainage and secondary wound closure. Wound management without secondary surgery, this includes invasive procedure without anesthesia such as aspiration of seroma and readmission for wound care such as intravenous antibiotic or persistent deep packing within 4 months (120 days) after surgery. |
120 days postoperatively | |
Secondary | Secondary outcome measures, hospital stay. | Length of hospital stay (measured in days) | 1 year postoperatively | |
Secondary | Secondary outcome measures, readmission. | Readmission to hospital for treatment of a wound complication (measured in days from primary surgery) | 1 year postoperatively | |
Secondary | Secondary outcome measures, primary wound healing. | Time to primary wound healing and removal of staples, ready for radiation therapy (measured in days from primary surgery) | 1 year postoperatively | |
Secondary | Secondary outcome measures, deep infection. | Deep infection (measured in days from primary surgery, any medical or surgical interventions will be described) | 1 year postoperatively | |
Secondary | Secondary outcome measures, seroma. | Postoperative seroma development (measured in days from primary surgery) | 1 year postoperatively | |
Secondary | Secondary outcome measures, MSTS. | Musculoskeletal Tumor Society Score (MSTS)
MSTS score is a physician-completed score containing following categories: Pain Function Emotional acceptance Support/Assistive device Walking Gait Maximum score is 30 (the value will often be presented in percentage of total). |
1 year postoperatively | |
Secondary | Secondary outcome measures, TESS. | Toronto Extremity Salvage Score (TESS)
TESS is a self-administrated questionnaire that evaluates physical disability, it consists of 29 questions for upper-extremity and 30 for lower-extremity. Each question is scored from 1-5, where 5 is given if there are no problems. Values will often be presented as a percentage of the total possible amount. |
1 year postoperatively | |
Secondary | Secondary outcome measures, 5Q-5D. | European Quality of Life - 5 Dimensions (EQ-5D)
EQ-5D is a self-reported questionnaire to evaluate the quality of life, it has 5 dimensions: Mobility Personal hygiene Usual activities Pain Anxiety/depression Each dimension is evaluated with a score of 1-5, where 1 is given to patients without problems. Each answer has a different weight in values and the values for a Danish population will be used in analysis. |
1 year postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|