Clinical trial NCT02509260: Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
Official title: A Randomized Controlled Trial of Prevena™ Incisional Negative Pressure Wound Therapy to Reduce Surgical Site Infection in Re-operative Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: colorectal surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Superficial Surgical Site Infection
timeFrame: within 30 days after the operation
Secondary outcomes:
measure: Length of Hospital Stay,
timeFrame: 30 days after operation
measure: Cost Effectiveness
timeFrame: 30 days after operation
measure: Clinical Efficacy of the Device in Relation to the Degree of Contamination
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: David Liska, MD
role: PRINCIPAL_INVESTIGATOR
References: