Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/9/2018 |
| Start Date: | December 2015 |
| End Date: | December 2020 |
| Contact: | Monica E Baczko, MPA |
| Email: | baczko@musc.edu |
| Phone: | 843-792-8169 |
Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds. A Prospective Randomized Clinical Trial
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.
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lee R Leddy, MD
Phone: 843-792-8169
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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