Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2019 |
| Start Date: | July 2015 |
| End Date: | December 2019 |
| Contact: | David Liska, MD |
| Email: | liskad@ccf.org |
| Phone: | 216 444-9219 |
A Randomized Controlled Trial of Prevena™ Incisional Negative Pressure Wound Therapy to Reduce Surgical Site Infection in Re-operative Colorectal Surgery
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and
Medicaid Services introduced the Surgical Care Improvement Project infection project with the
aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous
antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic
selection, discontinuation of prophylactic antibiotics within 24 hours after surgery,
appropriate hair removal, and maintenance of perioperative normothermia. Despite the
enforcement of these measures through quality reporting and pay-for-performance measures,
significant controversy exists as to their overall effectiveness, especially in the high-risk
colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in
the colorectal population; however, not all patients are appropriate candidates for this
approach and the inability of promising interventions such as wound edge protection and
gentamicin sponges to improve SSI rates following colorectal surgery mandate the
investigation of novel techniques.
The aim of the current study is to assess the clinical effectiveness of incisional NPWT to
reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study
is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints
include length of hospital stay and cost effectiveness.
Medicaid Services introduced the Surgical Care Improvement Project infection project with the
aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous
antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic
selection, discontinuation of prophylactic antibiotics within 24 hours after surgery,
appropriate hair removal, and maintenance of perioperative normothermia. Despite the
enforcement of these measures through quality reporting and pay-for-performance measures,
significant controversy exists as to their overall effectiveness, especially in the high-risk
colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in
the colorectal population; however, not all patients are appropriate candidates for this
approach and the inability of promising interventions such as wound edge protection and
gentamicin sponges to improve SSI rates following colorectal surgery mandate the
investigation of novel techniques.
The aim of the current study is to assess the clinical effectiveness of incisional NPWT to
reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study
is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints
include length of hospital stay and cost effectiveness.
Surgical site infections (SSIs) are a common problem and a significant cause of morbidity in
surgical patients. They present a substantial burden to the health care system in the United
States and contribute more than 1.6 billion dollars in excess cost and 1 million in extra
hospital days in affected patients. SSIs are associated with a multitude of complications
including an increased risk of incisional hernia and prolonged hospital stay. Despite optimum
surgical care there remains an inability to significantly reduce SSI rates following
colorectal surgery and this field represents a critical priority for study. When one examines
the control arms of recent high quality randomized controlled trials, the SSI rate following
colorectal surgery ranges from 22.0-26.1%, emphasizing the prevalence of this complication.
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and
Medicaid Services introduced the Surgical Care Improvement Project infection project with the
aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous
antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic
selection, discontinuation of prophylactic antibiotics within 24 hours after surgery,
appropriate hair removal, and maintenance of perioperative normothermia. Despite the
enforcement of these measures through quality reporting and pay-for-performance measures,
significant controversy exists as to their overall effectiveness, especially in the high-risk
colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in
the colorectal population; however, not all patients are appropriate candidates for this
approach and the inability of promising interventions such as wound edge protection6 and
gentamicin sponges4 to improve SSI rates following colorectal surgery mandate the
investigation of novel techniques.
Initiated in the orthopaedic literature, a new technique of wound dressing has been described
to reduce SSI. Incisional negative pressure wound therapy (NPWT) using devices such as the
Prevena™ involves applying a wound vacuum sponge over a standard wound closure (including
fascial closure and skin closure with staples). The incisional NPWT dressing is then left in
place for 5 to 7 days before removal. A recent retrospective study by Bonds et al. described
the ability of incisional NPWT to reduce SSI rates in open colorectal surgery from
29.3-12.5%.
The aim of the current study is to assess the clinical effectiveness of incisional NPWT to
reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study
is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints
include, length of hospital stay and cost effectiveness.
surgical patients. They present a substantial burden to the health care system in the United
States and contribute more than 1.6 billion dollars in excess cost and 1 million in extra
hospital days in affected patients. SSIs are associated with a multitude of complications
including an increased risk of incisional hernia and prolonged hospital stay. Despite optimum
surgical care there remains an inability to significantly reduce SSI rates following
colorectal surgery and this field represents a critical priority for study. When one examines
the control arms of recent high quality randomized controlled trials, the SSI rate following
colorectal surgery ranges from 22.0-26.1%, emphasizing the prevalence of this complication.
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and
Medicaid Services introduced the Surgical Care Improvement Project infection project with the
aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous
antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic
selection, discontinuation of prophylactic antibiotics within 24 hours after surgery,
appropriate hair removal, and maintenance of perioperative normothermia. Despite the
enforcement of these measures through quality reporting and pay-for-performance measures,
significant controversy exists as to their overall effectiveness, especially in the high-risk
colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in
the colorectal population; however, not all patients are appropriate candidates for this
approach and the inability of promising interventions such as wound edge protection6 and
gentamicin sponges4 to improve SSI rates following colorectal surgery mandate the
investigation of novel techniques.
Initiated in the orthopaedic literature, a new technique of wound dressing has been described
to reduce SSI. Incisional negative pressure wound therapy (NPWT) using devices such as the
Prevena™ involves applying a wound vacuum sponge over a standard wound closure (including
fascial closure and skin closure with staples). The incisional NPWT dressing is then left in
place for 5 to 7 days before removal. A recent retrospective study by Bonds et al. described
the ability of incisional NPWT to reduce SSI rates in open colorectal surgery from
29.3-12.5%.
The aim of the current study is to assess the clinical effectiveness of incisional NPWT to
reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study
is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints
include, length of hospital stay and cost effectiveness.
Inclusion Criteria:
- 18 years of age
- re-operative colorectal surgery
- excision or revision of prior anastomosis
- intestinal resection
- incisional hernia repair
- enterocutaneous fistula repair
- emergency settings
Exclusion Criteria:
- Laparoscopic or laparoscopic assisted procedures
- patients who had undergone a laparotomy within the preceding three months
- an active SSI at the time of surgery
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