Herniorrhaphy, Abdominoplasty
Conditions
Brief summary
The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to SOC dressing, and to significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing.
Interventions
DEVICECustomizable Dressing with ActiV.A.C. Therapy Unit
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: 1. an adult 18 years old or older of either gender 2. able to provide their own informed consent 3. will undergo: 1. a functional panniculectomy with a transverse or a fleur-de-lis incision * AND/OR - 2. an incisional hernia repair with a vertical incision at least 20 cm in length and at least 10 cm of undermining on each side of the incision 4. BMI equal to or greater than 30 5. has maintained a stable weight for at least 3 months as determined by the Investigator (applies to post weight loss patients only) 6. 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 7. willing and able to return for all scheduled study visits 8. if a female of child-bearing potential, must test negative on a urine pregnancy test 9. if a female of child-bearing potential, must be willing to utilize an acceptable method of birth control (i.e. oral contraceptives, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch) for the duration of the study Intra-Operative Inclusion Criteria: 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 Customizable dressing Pre-Operative
Exclusion criteria
1. has a systemic bacterial or fungal infection at the time of surgery for incisional hernia repair and/or functional panniculectomy 2. has a remote-site skin infection at the time of surgery for incisional hernia repair or functional panniculectomy 3. pre-operatively 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 4. will have a transverse or fleur-de-lis incision that extends beyond the flank area and requires moving the Subject from the supine position during surgery 5. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives 6. has participated in a clinical study within the past 30 days 7. who, in the investigator's opinion, would have any clinically significant condition that would impair the Subject's ability to comply with the study procedures Post-Operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Complications | Within 30 Days Post-Surgical Procedure | Surgical Site Complications: * Dehiscence * Surgical site infection (SSI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care dry sterile dressing/gauze and steristrips
Standard of Care Dressing | 34 |
| Customizable Customizable Dressing with ActiV.A.C. Therapy Unit
Customizable Dressing with ActiV.A.C. Therapy Unit | 36 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 4 |
| Overall Study | Treatment discontinued before day 5 | 0 | 1 |
| Overall Study | Withdrawn prior to any treatment | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Customizable |
|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 7.79 | 42.5 years STANDARD_DEVIATION 7.78 | 41.8 years STANDARD_DEVIATION 7.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 56 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 14 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 4 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 | 29 Participants | 60 Participants | 31 Participants |
| Region of Enrollment United States | 34 participants | 70 participants | 36 participants |
| Sex: Female, Male Female | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 36 |
| other Total, other adverse events | 2 / 34 | 7 / 36 |
| serious Total, serious adverse events | 0 / 34 | 2 / 36 |
Outcome results
Primary
Number of Participants With Surgical Site Complications
Surgical Site Complications: * Dehiscence * Surgical site infection (SSI)
Time frame: Within 30 Days Post-Surgical Procedure
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With Surgical Site Complications | 1 Participants |
| Customizable | Number of Participants With Surgical Site Complications | 5 Participants |
p-value: 0.198195% CI: [-0.016, 0.243]Fisher Exact