Familial Polyposis, Ulcerative Colitis
Conditions
Brief summary
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.
Interventions
DEVICESprayShield Adhesion Barrier System
Adhesion Barrier Device
PROCEDUREGood Surgical Technique Alone
Good Surgical Technique Alone
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity. | 10-12 Weeks post Initial Surgery for J-Pouch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Adhesions | Average 10-12 weeks post surgery | Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are 1, 2, and 3. Subjects without adhesions were assigned a severity rating of 0. |
| Adhesion Involvement Along the Midline Incision (Percentage) | average 10-12 weeks post surgery | The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage. |
| Mobilization Time | average 10-12 weeks post surgery | The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure. |
Countries
United States
Participant flow
Recruitment details
Study Initiation: 31October2009 Study Termination: 24March2010 Study was conducted in hospitals.
Participants by arm
| Arm | Count |
|---|---|
| SprayShield Adhesion Barrier SprayShield Adhesion Barrier + Good Surgical Technique | 8 |
| Control Good Surgical Technique Alone | 3 |
| Total | 11 |
Baseline characteristics
| Characteristic | SprayShield Adhesion Barrier | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 10 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 12.6 | 37.7 years STANDARD_DEVIATION 19.8 | 45.5 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment Czech Republic | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Poland | 5 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 8 | 0 / 3 |
| serious Total, serious adverse events | 2 / 8 | 1 / 3 |
Outcome results
Primary
The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
Time frame: 10-12 Weeks post Initial Surgery for J-Pouch
Population: All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SprayShield Adhesion Barrier | The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity. | 37.5 percentage of subjects with adhesions |
| Control | The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity. | 66.7 percentage of subjects with adhesions |
Secondary
Adhesion Involvement Along the Midline Incision (Percentage)
The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.
Time frame: average 10-12 weeks post surgery
Population: These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) \* 100.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield Adhesion Barrier | Adhesion Involvement Along the Midline Incision (Percentage) | 66.7 percentage of midline incision | Standard Deviation 0 |
| Control | Adhesion Involvement Along the Midline Incision (Percentage) | 76.3 percentage of midline incision | Standard Deviation 33.5 |
Secondary
Mobilization Time
The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.
Time frame: average 10-12 weeks post surgery
Population: All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield Adhesion Barrier | Mobilization Time | 41.0 minutes | Standard Deviation 13.7 |
| Control | Mobilization Time | 43.3 minutes | Standard Deviation 2.9 |
Secondary
Severity of Adhesions
Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are 1, 2, and 3. Subjects without adhesions were assigned a severity rating of 0.
Time frame: Average 10-12 weeks post surgery
Population: All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield Adhesion Barrier | Severity of Adhesions | 0.9 units on a scale | Standard Deviation 1.2 |
| Control | Severity of Adhesions | 1.3 units on a scale | Standard Deviation 1.2 |