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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.
The investigators will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.
Postoperative surgical site infections pose a significant challenge to the orthopaedic oncologist, especially in wounds that have been previously irradiated with neo adjuvant external beam radiation therapy (EBRT). There are many studies demonstrating the relatively high risk of wound complications after lower extremity sarcoma resection. Published data suggest that these preoperatively radiated wounds have a postoperative infection rate of 17%-44% with "traditional" dressings (e.g. dry gauze surgical dressings).
A prospective series of 190 patients and showed a wound complication risk of 35% in preoperative irradiated wounds. The morbidity associated with wound complications can range from moderate (prolonged dressing changes) to severe (life or limb threatening infection). Patients who develop wound complications have been shown to longer hospitalizations and higher costs [ref]. Anatomic location of the tumor has been shown to be a risk factor for the development of wound complications with lower extremities being higher risk than upper extremities. There are several published studies examining the effect of negative pressure wound therapy (NPWT) on high risk surgical wounds. Abdominal wound complications can be reduced with the use of incisional NPWT. In the orthopaedic literature the use of negative pressure incisional dressings have been shown to lower the risk of wound complications in total hip arthroplasty, acetabular fractures, and extremity fractures.
To our knowledge, there have not been any published studies on the utility of negative pressure wound therapy in previously irradiated soft tissue sarcoma wounds. The investigators feel that this high risk patient cohort could potentially benefit from reducing wound complications through NPWT and is an ideal population to study its effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT dressing | Experimental |
| |
| Standard dry gauze dressing | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevana Dressing | Device | negative pressure wound therapy (NPWT) dressing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication Rate | To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable). | longitudinally up to 6 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee R Leddy, MD | Medical University of South Carolins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Data safety and monitoring will be provided by the Hollings Cancer Center DSMC. This committee will serve for all sites. The DSMC meets 6 times a year and reviews all MUSC IRB adverse events, protocol deviations/violations, early stopping rules and internal audit results. The PI will be responsible for identifying, reviewing monthly, and reporting adverse events.
Individual participant data will not be shared between the sites. All data will be deidentified and linked with a code.
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Patients were randomized to NPWT or dry gauze dressing following oncologic resection and were excluded in the settings of amputation, revision, or flap coverage
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| ID | Title | Description |
|---|---|---|
| FG000 | NPWT Dressing | Prevana Dressing: negative pressure wound therapy (NPWT) dressing |
| FG001 | Standard Dry Gauze Dressing | Standard Dry Gauze Dressing: Standard Dry Gauze Dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were not collected for sex of participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | NPWT Dressing | Prevana Dressing: negative pressure wound therapy (NPWT) dressing. Baseline characteristics were not collected for sex of participants, nor was the age documented as a result of all participants being over the age of 18. |
| BG001 | Standard Dry Gauze Dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Complication Rate | To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable). | Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | longitudinally up to 6 months postoperatively |
|
up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NPWT Dressing | Prevana Dressing: negative pressure wound therapy (NPWT) dressing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leddy | Medical University of South Carolina | 843-876-1119 | leddyl@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2023 | Jul 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D009369 | Neoplasms |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D007239 | Infections |
| D020969 | Disease Attributes |
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| Standard Dry Gauze Dressing |
| Other |
Standard Dry Gauze Dressing |
|
Standard Dry Gauze Dressing: Standard Dry Gauze Dressing. Baseline characteristics were not collected for sex of participants, nor was the age documented as a result of all participants being over the age of 18. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard Dry Gauze Dressing | Standard Dry Gauze Dressing: Standard Dry Gauze Dressing |
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Standard Dry Gauze Dressing | Standard Dry Gauze Dressing: Standard Dry Gauze Dressing | 0 | 79 | 0 | 79 | 0 | 79 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |