Hernia, Surgical Wound Dehiscence
Conditions
Keywords
dehiscence, laparotomy, Hernia repair, surgical wound, surgical mesh
Brief summary
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.
Detailed description
This is a prospective, multicenter, single-blind, randomized, longitudinal, cross-over evaluation of the repair of challenging abdominal wall defects using Strattice(TM) TM or standard surgical repair. These abdominal wall defects can be acute or chronic, and include midline, transverse (including flank) as well as Pfannenstiel incisions. The skin may be closed (fascial dehiscence or incisional hernia) or open (patient with open abdomen or acute fascial dehiscence) with or without evisceration. Patients randomized to the control group who require a re-operation to perform the planned final repair or due to failure of the initial repair within 12 months, will be offered repair with Strattice™ TM (i.e. crossed over) or if such repair not performed, the patient will have completed the study. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the three conditions (type of defect \[dehiscence, hernia repair or open abdomen\], morbidity \[POSSUM score\] and time since exposure of abdominal fascia/viscera) will be used to equally distribute subjects between groups. The primary endpoint of this study is hernia occurrence at 12 months post repair and secondary endpoints include re-operation for abdominal wall repair within 12 months, incidence of complications requiring intervention(medical or surgical) within the first 30 days after repair,, length of hospitalization and resource utilization, and all cause mortality. Subjects will be enrolled and randomized to receive Strattice(TM) TM reinforcement of repair or standard of care repair (i.e. suture alone or suture with absorbable mesh) and followed at set timepoints to observe incision site repair for surgical site events, including reoperation and hernia occurrence.
Interventions
DEVICEStrattice(TM) Reconstructive Tissue Matrix
Strattice(TM) TM will be used to support the repair of abdominal wall defect
PROCEDURESuture/suture with absorbable mesh
Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture
Sponsors
LifeCell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults (18years of age or older) who is able to provide written informed consent for study participation * has need of surgical intervention for repair of (potentially) contaminated abdominal wall defect of \>3cm and \<22cm in length, where the viscera have not been exposed for more than 15 days in case of open abdomen(skin and fascia open). * Is willing and able to return for all scheduled & required study visit.
Exclusion criteria
at the time of randomization * severe systemic sepsis * frank pus in the wound, a fistula that will not be closed at the time of surgery or intra-abdominal abscess in surgical area, * ongoing necrotizing pancreatitis, * Is on chronic immunosuppressive therapy, or other medication that influences wound healing * requires only short-term temporary closure, * requires a synthetic, non-absorbable mesh to close the abdominal wall defect * is unable to undergo general anesthesia, * has other major organ system dysfunction or disorder that would jeopardize subject completing the 24 month study. * Is unable to undergo an MRI scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Occurrence | Month 12 after repair | Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained. |
Countries
France, Germany, Italy, Netherlands, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Strattice(TM) TM Repair Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect | 18 |
| Standard of Care Repair Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | Strattice(TM) TM Repair | Standard of Care Repair | Total |
|---|---|---|---|
| Age Continuous | 70 years STANDARD_DEVIATION 9.94 | 67 years STANDARD_DEVIATION 8.49 | 68.5 years STANDARD_DEVIATION 9.22 |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 18 | 15 / 19 |
| serious Total, serious adverse events | 7 / 18 | 8 / 19 |
Outcome results
Primary
Hernia Occurrence
Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.
Time frame: Month 12 after repair
Population: Due to early termination of the study and the low enrollment number (only 37 subjects out of the planned 200 subjects being enrolled), all planned analyses of study endpoints were not performed. The only study results obtained focused on safety. Due to the small sample size these safety results should be interpreted with caution.