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| Name | Class |
|---|---|
| Cook Biotech Incorporated | INDUSTRY |
| Cook Ireland, Ltd. | INDUSTRY |
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The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Surgisis® AFP |
|
| 2 | Active Comparator | Flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) | Device | Surgical placement of the Surgisis AFP is performed under general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing Success | Healing was defined as "closure of external opening with absence of abscess, drainage and pain." | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thilo Schwandner, MD | Justus-Liebig-Universitat Giessen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Justus-Liebig-Universitat Giessen | Giessen | Giessen | 35385 | Germany | ||
| Krankenhaus Waldfriede |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgisis® AFP | Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia. |
| FG001 | Flap | Flap: Advancement flap surgery is performed; no anal fistula plug is placed |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients that were not treated were not included in the analysis. There was 1 patient in the Surgisis arm and 3 patients in the Flap arm that were not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgisis® AFP | Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia. |
| BG001 | Flap | Flap: Advancement flap surgery is performed; no anal fistula plug is placed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One patient in the SurgiSIS AFP arm has age missing. |
| 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 | Healing Success | Healing was defined as "closure of external opening with absence of abscess, drainage and pain." | Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated. | Posted | Number | participants | 12 months |
|
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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 | Surgisis® AFP | Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration / Redness / Swelling Involving External Opening | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fistula tract re-opened after closure had been documented | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hodde, Clinical Affairs Manager | Cook Biotech Incorporated | 765-497-3355 | jhodde@cookbiotech.com |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D013524 | Surgical Flaps |
| ID | Term |
|---|---|
| D019738 | Surgically-Created Structures |
| D004864 | Equipment and Supplies |
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| Flap | Device | Advancement flap surgery is performed; no anal fistula plug is placed |
|
| Berlin |
| Germany |
| End-und Dickdarmzentrum Hannover | Hanover | Germany |
| Enddarmzentrum Mannheim | Mannheim | Germany |
| Caritas-Krankenhaus St. Joseph | Regensburg | Germany |
| St. Joseph Hospital | Wiesbaden | Germany |
| Technical failure |
|
| Withdrawal by Subject |
|
| Persistence or recurrence of fistula |
|
| Patients were not treated |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Flap: Advancement flap surgery is performed; no anal fistula plug is placed
|
|
|
| 1 |
| 43 |
| 7 |
| 43 |
| EG001 | Flap | Flap: Advancement flap surgery is performed; no anal fistula plug is placed | 2 | 39 | 5 | 39 |
| Fistula Tract Re-Opened After Closure had been Documented | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Newly apparent fistula opening | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Induration / Redness / Swelling involving external opening | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection / Abscess involving fistula | Infections and infestations | Systematic Assessment |
|
| Plug fell out or flap failed | Surgical and medical procedures | Systematic Assessment |
|
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| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |