Cancer, Infectious Disease, Sarcoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPrevana Dressing
negative pressure wound therapy (NPWT) dressing
OTHERStandard Dry Gauze Dressing
Standard Dry Gauze Dressing
Sponsors
3M
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 * Willing to consent to randomization and able to participate in the study * Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection * Primary closure of wound * Patients scheduled for surgical resection
Exclusion criteria
* Flap coverage or skin graft * Patients scheduled for amputations as local control of their tumor * Sarcomas where radiation is not planned preoperatively * Repeat surgeries for oncologic reasons (positive margins) * Known allergy to adhesive tape
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complication Rate | longitudinally up to 6 months postoperatively | 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). |
Countries
United States
Participant flow
Recruitment details
Patients were randomized to NPWT or dry gauze dressing following oncologic resection and were excluded in the settings of amputation, revision, or flap coverage
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 79 |
| Total | 160 |
Baseline characteristics
| Characteristic | Standard Dry Gauze Dressing | Total | NPWT Dressing |
|---|---|---|---|
| Age, Customized >=18 years old | 79 Participants | 160 Participants | 81 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 79 participants | 160 participants | 81 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 79 |
| other Total, other adverse events | 0 / 81 | 0 / 79 |
| serious Total, serious adverse events | 0 / 81 | 0 / 79 |
Outcome results
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).
Time frame: longitudinally up to 6 months postoperatively
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NPWT Dressing | Wound Complication Rate | Post-operative pain severity assessed by Visual analogue scale at 2 weeks postoperatively. | 3.7 score on a scale | Standard Deviation 2.2 |
| NPWT Dressing | Wound Complication Rate | Post-operative pain severity assessed by Visual analogue scale at 6 months postoperatively. | 2.1 score on a scale | Standard Deviation 1.9 |
| Standard Dry Gauze Dressing | Wound Complication Rate | Post-operative pain severity assessed by Visual analogue scale at 2 weeks postoperatively. | 3.7 score on a scale | Standard Deviation 2.5 |
| Standard Dry Gauze Dressing | Wound Complication Rate | Post-operative pain severity assessed by Visual analogue scale at 6 months postoperatively. | 2.2 score on a scale | Standard Deviation 1.9 |