Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
Conditions
Keywords
surgical site infection, nosocomial infection, post-operative complication, surgical incision risk, surgical incision infection, negative pressure wound therapy, wound management, cesarean section surgery, wound dehiscence, wound infection, surgical closure, wound disruption, subcutaneous approximation, wound separation, seroma, hematoma, subcutaneous closure, obesity, cesarean, incision, massive obesity, obese, pregnancy, cesarean delivery, superobesity, wound complication
Brief summary
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
Detailed description
This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevena™ Incision Management System (PIMS) on Cesarean section Subjects compared to a control arm treated with a standard-of-care surgical incision dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PIMS on closed incisions. Clinical outcomes of interest for this study are defined as Surgical Site Occurrences (SSOs) that include unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, and surgical site infection (SSI). This investigation will compare these outcomes to a control group consisting of Subjects screened for the same inclusion and exclusion criteria but treated with a standard-of-care surgical incision dressing.
Interventions
DEVICEPrevena™ Incision Management System (PIMS)
PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
DEVICEStandard-of-care Dressing
The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The Subject: 1. is a female aged ≥ 18 years 2. is able to provide her own informed consent 3. will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days 4. will require a surgical incision able to be covered completely by the PIMS skin interface 5. has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery 6. is preoperatively 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 7. is willing and able to return for all scheduled and required study visits 8. is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site
Exclusion criteria
The Subject: 1. is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System) 2. has a systemic bacterial or fungal infection at the time of surgery 3. has a remote-site skin infection at the time of surgery 4. has a life expectancy of \< 12 months 5. 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 6. experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC) or other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration 7. who, in the investigator's opinion, would have any clinically significant condition that would impair the participant's ability to comply with the study procedures 8. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Post-op Day 42 (+/- 10 days) after Cesarean section surgery | Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Post-op Day: 42 (+/- 10 days) after Cesarean section surgery | Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include: * Antimicrobials for surgical site infection * Surgical drainage of the incision * Surgical incision packing * Adjunctive negative pressure therapy * Debridement * Re-operation |
Countries
United States
Participant flow
Recruitment details
Subjects for the study were recruited from a hospital Labor and Delivery Unit. Recruitment period: 26JAN2012 (site initiation) - 17DEC2013 (LPO)
Participants by arm
| Arm | Count |
|---|---|
| Standard Dressing Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy. | 46 |
| Prevena™ (PIMS) PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. | 46 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Dressing | Total | Prevena™ (PIMS) |
|---|---|---|---|
| Age, Continuous | 29.67 years STANDARD_DEVIATION 4.953 | 30.01 years STANDARD_DEVIATION 5.334 | 30.35 years STANDARD_DEVIATION 5.724 |
| BMI (kg/m2) | 46.79 kg/m2 STANDARD_DEVIATION 5.608 | 46.52 kg/m2 STANDARD_DEVIATION 6.489 | 46.25 kg/m2 STANDARD_DEVIATION 7.319 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 87 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age (weeks) | 37.87 weeks STANDARD_DEVIATION 1.976 | 37.97 weeks STANDARD_DEVIATION 1.972 | 38.08 weeks STANDARD_DEVIATION 1.983 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 64 Participants | 29 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 | 10 Participants | 27 Participants | 17 Participants |
| Region of Enrollment United States | 46 participants | 92 participants | 46 participants |
| Sex: Female, Male Female | 46 Participants | 92 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 46 | 12 / 46 |
| serious Total, serious adverse events | 2 / 46 | 4 / 46 |
Outcome results
Primary
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)
Time frame: Post-op Day 42 (+/- 10 days) after Cesarean section surgery
Population: The Per-protocol Population was used for primary and secondary endpoint analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Dressing | Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | 7 participants |
| Prevena™ (PIMS) | Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | 2 participants |
Secondary
Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include: * Antimicrobials for surgical site infection * Surgical drainage of the incision * Surgical incision packing * Adjunctive negative pressure therapy * Debridement * Re-operation
Time frame: Post-op Day: 42 (+/- 10 days) after Cesarean section surgery
Population: The Per-protocol Population was used for primary and secondary endpoint analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Dressing | Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | 6 participants |
| Prevena™ (PIMS) | Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | 1 participants |