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Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery

A Randomized Controlled Trial of Prevena™ Incisional Negative Pressure Wound Therapy to Reduce Surgical Site Infection in Re-operative Colorectal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02509260
Enrollment
298
Registered
2015-07-27
Start date
2015-07-31
Completion date
2021-02-19
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

colorectal surgery

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.

Interventions

DEVICEPrevena wound management system

Patients will have the Prevena wound management system applied post-operatively.

Control patients with standard wound dressings will have gauze and tape dressings applied

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of Superficial Surgical Site Infectionwithin 30 days after the operationDiagnosis will be based on criteria developed by the Centers for Disease Control (CDC)

Secondary

MeasureTime frameDescription
Length of Hospital Stay,30 days after operationnumber of days in hospital after surgery day
Cost Effectiveness30 days after operationratio of costs between intervention and control group
Clinical Efficacy of the Device in Relation to the Degree of Contamination30 days after operationdifference in SSI between groups

Countries

United States

Participant flow

Participants by arm

ArmCount
Prevena™ Incisional NPWT
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied. Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
149
Standard Wound Dressings
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied. Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
149
Total298

Baseline characteristics

CharacteristicPrevena™ Incisional NPWTStandard Wound DressingsTotal
Age, Continuous49.8 years
STANDARD_DEVIATION 16.4
52.2 years
STANDARD_DEVIATION 15.1
51 years
STANDARD_DEVIATION 15.8
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
74 Participants73 Participants147 Participants
Sex: Female, Male
Male
75 Participants76 Participants151 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1491 / 149
other
Total, other adverse events
92 / 14984 / 149
serious
Total, serious adverse events
11 / 14919 / 149

Outcome results

Primary

Occurrence of Superficial Surgical Site Infection

Diagnosis will be based on criteria developed by the Centers for Disease Control (CDC)

Time frame: within 30 days after the operation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Prevena™ Incisional NPWTOccurrence of Superficial Surgical Site InfectionSuperficial Surgical Site Infection11 Participants
Prevena™ Incisional NPWTOccurrence of Superficial Surgical Site InfectionNo Superficial Surgical Site Infection107 Participants
Standard Wound DressingsOccurrence of Superficial Surgical Site InfectionSuperficial Surgical Site Infection21 Participants
Standard Wound DressingsOccurrence of Superficial Surgical Site InfectionNo Superficial Surgical Site Infection128 Participants
Secondary

Clinical Efficacy of the Device in Relation to the Degree of Contamination

difference in SSI between groups

Time frame: 30 days after operation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Prevena™ Incisional NPWTClinical Efficacy of the Device in Relation to the Degree of ContaminationClean-Contaminated15 Participants
Prevena™ Incisional NPWTClinical Efficacy of the Device in Relation to the Degree of ContaminationDirty39 Participants
Prevena™ Incisional NPWTClinical Efficacy of the Device in Relation to the Degree of ContaminationContaminated94 Participants
Prevena™ Incisional NPWTClinical Efficacy of the Device in Relation to the Degree of ContaminationNo contamination1 Participants
Standard Wound DressingsClinical Efficacy of the Device in Relation to the Degree of ContaminationContaminated90 Participants
Standard Wound DressingsClinical Efficacy of the Device in Relation to the Degree of ContaminationClean-Contaminated12 Participants
Standard Wound DressingsClinical Efficacy of the Device in Relation to the Degree of ContaminationNo contamination2 Participants
Standard Wound DressingsClinical Efficacy of the Device in Relation to the Degree of ContaminationDirty45 Participants
Secondary

Cost Effectiveness

ratio of costs between intervention and control group

Time frame: 30 days after operation

Population: Study team ultimately decided not to collect this data

Secondary

Length of Hospital Stay,

number of days in hospital after surgery day

Time frame: 30 days after operation

ArmMeasureValue (MEDIAN)
Prevena™ Incisional NPWTLength of Hospital Stay,7 Days
Standard Wound DressingsLength of Hospital Stay,6 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026