Surgical Site Reaction
Conditions
Brief summary
This study is being conducted to see how safe and effective the Prevena Incision Management System Prevena is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy. Prevena will be tested while applied during the time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small portable negative pressure device which consists of a therapy unit that delivers negative pressure. It also includes a dressing system that is intended for use over closed incisions after surgery. The intent of this study is to evaluate Prevena versus the standard care that a doctor would use normally after a kidney transplant.
Detailed description
This is a randomized, single-center, comparative interventional study looking at the effect of Prevena™ on renal transplant surgical Subjects compared to a control arm treated with the standard-of-care wound dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PrevenaTM in this clinical indication.
Interventions
It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).
OTHERStandard of Care for Surgical Incisions
Sterile 4X4 Non-Penetrable barrier
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-operative Inclusion Criteria The Subject: 1. is an adult ≥ 18 years old of either gender 2. is able to provide their own informed consent Protocol: AHS.2012.Prevena.Cooper.01 v 4.0 Confidential/Property of KCI USA, Inc. Page 6 of 71 3. will undergo open renal transplant surgery within the next 30 days 4. will require a surgical incision able to be covered completely by the PIMS dressing 5. is pre-operatively assessed to undergo a procedure with a CDC Wound Classification of: 1. Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered \- OR - 2. Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination 6. is willing and able to return for all scheduled and required study visits 7. if female, must test negative on serum pregnancy test 8. if a female of child-bearing potential, must be willing to utilize an acceptable method of birth control (e.g., birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc.) for the duration of study participation 9. is not concurrently enrolled in a clinical trial which may impact subject health or the surgical incision site Intra-operative Inclusion Criteria Subjects must meet the following intra-operative inclusion criteria to be eligible for randomization. The Subject: 1. continues to meet all pre-operative inclusion criteria 2. has undergone a Class I or II CDC Wound Classification procedure resulting in a closed surgical incision able to be covered completely by the PIMS dressing Pre-operative
Exclusion criteria
The Subject: 1. has a BMI \< 18.5 kg/m2 and \> 40 kg/m2 2. has a systemic infection at the time of open renal transplant surgery 3. has a remote-site skin infection at the time of open renal transplant surgery 4. is preoperatively assessed to undergo a procedure with a CDC Wound Classification of: 1. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract \- OR - 2. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera 5. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives Intra-Operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Complications (SSCs) | 62 Days | The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevena Incision Management System Negative Pressure Therapy Device
Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT). | 31 |
| Standard of Care for Surgical Incisions Sterile gauze and a non-penetrable barrier
Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier | 32 |
| Total | 63 |
Baseline characteristics
| Characteristic | Standard of Care for Surgical Incisions | Total | Prevena Incision Management System |
|---|---|---|---|
| Age, Continuous | 51.75 years STANDARD_DEVIATION 12.19 | 50.25 years STANDARD_DEVIATION 11.76 | 48.71 years STANDARD_DEVIATION 11.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 57 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 32 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Female | 13 Participants | 22 Participants | 9 Participants |
| Sex: Female, Male Male | 19 Participants | 41 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 11 / 31 | 13 / 32 |
Outcome results
Primary
Number of Participants With Surgical Site Complications (SSCs)
The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.
Time frame: 62 Days
Population: Analysis of this endpoint was based on the Full analysis Set (FAS population). The FAS population consists of participants who met all of the pre- and intra-operative eligibility criteria, were randomized and received treatment. Subjects without SSC must have received 5 days of Prevena or at least 3 days of SOC dressing and completed 30 day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena Incision Management System | Number of Participants With Surgical Site Complications (SSCs) | 6 Participants |
| Standard of Care for Surgical Incisions | Number of Participants With Surgical Site Complications (SSCs) | 8 Participants |