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terminated due to inability to complete the study
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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh Implantation | Device | Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Wound Occurrences | Number of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hernia Formation | The incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and at 6 months from the date of ileostomy closure. | 30 days, 6 months |
| Quality of Life After Mesh Implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Z Wilson, MD, Msc | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32577580 | Background | Goldwag JL, Wilson LR, Ivatury SJ, Pauli EM, Tsapakos MJ, Wilson MZ. Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial. Contemp Clin Trials Commun. 2020 Jun 9;19:100582. doi: 10.1016/j.conctc.2020.100582. eCollection 2020 Sep. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Wound Occurrences | Number of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed. | One participant had no day 30 data collected due to early study closure and was therefore not included in the analysis population | Posted | Count of Participants | Participants | 30 days |
|
30 days.
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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 | Intervention | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation. Protocol intended to collect study data including adverse events through 6-months. The study was terminated early, and no outcome data are available in the study records beyond day 30. As a result, no data are available for analysis or reporting at the planned 6-month time point. AE data is reported for day 30, reflective of the study data available. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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Resource limitations resulted incomplete data on most participants as well as early termination and low total enrollment numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Wilson | Dartmouth-Hitchcock Medical Center | 603-650-8113 | Matthew.z.wilson@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2021 | Nov 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period
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Patient will be evaluated with regards to their quality-of-life outcomes the Patient-Reported Outcome Measurement Information System Short Form (PROMIS SF) 2.0, Ability to Participate in Social Roles and Activities, instrument at 30 days and 6 months from the date of ileostomy closure.
Data represents mean and standard deviation of the normalized scores. Range for PROMIS Physical Health Score is 16-68 with a higher score being a more positive view, healthy people score 50+ Range for PROMIS Mental Health Score is 21-68, with a higher score representing better functioning, health people score 50+
| 30 days, 6 months |
| Bowel Function After Mesh Implantation | Patient will be evaluated with regards to their bowel function using the Colorectal Functional Outcome (COREFO) instrument at 30 days and 6 months from the date of ileostomy closure. Scores range from 0-100 with lower scores meaning better function (0- No symptoms/ Normal function; 100- Maximum impairment/ worst bowel function) | 30 days, 6 months |
| Participants |
|
| Sex/Gender, Customized | Data on Sex/Gender were not collected on this study | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Incidence of Hernia Formation | The incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and at 6 months from the date of ileostomy closure. | Day 30 data was missed on one participant. The study was terminated early, and no outcome data are available in the study records for the 6-month time point. As a result, no data are available for analysis or reporting at the planned 6-month time point. | Posted | Count of Participants | Participants | 30 days, 6 months |
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|
|
| Secondary | Quality of Life After Mesh Implantation | Patient will be evaluated with regards to their quality-of-life outcomes the Patient-Reported Outcome Measurement Information System Short Form (PROMIS SF) 2.0, Ability to Participate in Social Roles and Activities, instrument at 30 days and 6 months from the date of ileostomy closure. Data represents mean and standard deviation of the normalized scores. Range for PROMIS Physical Health Score is 16-68 with a higher score being a more positive view, healthy people score 50+ Range for PROMIS Mental Health Score is 21-68, with a higher score representing better functioning, health people score 50+ | Data incomplete, partial data was collected and is analyzed for day 30. The study was terminated early, and no outcome data are available in the study records for the 6-month time point. As a result, no data are available for analysis or reporting at the planned 6-month time point. The Patient-Reported Outcome Measurement Information System Short Form (PROMIS SF) 2.0 is a standardized and validated questionnaire with results | Posted | Mean | Standard Deviation | score on a scale | 30 days, 6 months |
|
|
|
| Secondary | Bowel Function After Mesh Implantation | Patient will be evaluated with regards to their bowel function using the Colorectal Functional Outcome (COREFO) instrument at 30 days and 6 months from the date of ileostomy closure. Scores range from 0-100 with lower scores meaning better function (0- No symptoms/ Normal function; 100- Maximum impairment/ worst bowel function) | Data incomplete, partial data was collected and is analyzed for day 30. The study was terminated early, and no outcome data are available in the study records for the 6-month time point. As a result, no data are available for analysis or reporting at the planned 6-month time point. | Posted | Mean | Standard Deviation | score on a scale | 30 days, 6 months |
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| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Month 6 PROMIS SF Global Physical Health Raw Assessment Score |
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| Month 6 PROMIS SF Global Mental Health Raw Assessment Score |
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