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Study was terminated for business purposes, not for safety or efficacy reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SprayShield Adhesion Barrier | Experimental | SprayShield Adhesion Barrier |
|
| Control | Sham Comparator | Good Surgical Technique Alone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SprayShield Adhesion Barrier System | Device | Adhesion Barrier Device |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Average 10-12 weeks post surgery |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covidien | Bedford | Massachusetts | 01710 | United States |
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Study Initiation: 31October2009 Study Termination: 24March2010
Study was conducted in hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | SprayShield Adhesion Barrier | SprayShield Adhesion Barrier + Good Surgical Technique |
| FG001 | Control | Good Surgical Technique Alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Good Surgical Technique Alone |
| Procedure |
Good Surgical Technique Alone |
|
| 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. | average 10-12 weeks post surgery |
| Mobilization Time | The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure. | average 10-12 weeks post surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SprayShield Adhesion Barrier | SprayShield Adhesion Barrier + Good Surgical Technique |
| BG001 | Control | Good Surgical Technique Alone |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan. | Posted | Number | percentage of subjects with adhesions | 10-12 Weeks post Initial Surgery for J-Pouch |
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| 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". | All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan. | Posted | Mean | Standard Deviation | units on a scale | Average 10-12 weeks post surgery |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of midline incision | average 10-12 weeks post surgery |
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| Secondary | Mobilization Time | The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure. | All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan. | Posted | Mean | Standard Deviation | minutes | average 10-12 weeks post surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SprayShield Adhesion Barrier | SprayShield Adhesion Barrier + Good Surgical Technique | 2 | 8 | 4 | 8 | ||
| EG001 | Control | Good Surgical Technique Alone | 1 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fasciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Surgical Skin Tear | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Impaired Healing | General disorders | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
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Early termination leading to small numbers of subjects analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefani Battaglia | Integra LifeSciences | 44 7880 732691 | stefani.battaglia@integralife.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| >=65 years |
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| Male |
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| Poland |
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