Trial Outcomes & Findings for Stoma Closure and Reinforcement Trial ll (NCT NCT04916067)
NCT ID: NCT04916067
Last Updated: 2026-02-27
Results Overview
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.
TERMINATED
NA
8 participants
30 days
2026-02-27
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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8
|
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Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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
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|---|---|
|
Overall Study
Early study closure due to lack of resources
|
8
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Baseline Characteristics
Data on Sex/Gender were not collected on this study
Baseline characteristics by cohort
| Measure |
Intervention
n=8 Participants
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
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
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8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: One participant had no day 30 data collected due to early study closure and was therefore not included in the analysis population
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.
Outcome measures
| Measure |
Intervention
n=7 Participants
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
|
|---|---|
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Number of Wound Occurrences
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0 Participants
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SECONDARY outcome
Timeframe: 30 days, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=7 Participants
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
|
|---|---|
|
Incidence of Hernia Formation
Day 30
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0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 monthsPopulation: 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
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+
Outcome measures
| Measure |
Intervention
n=4 Participants
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
|
|---|---|
|
Quality of Life After Mesh Implantation
Day 30 PROMIS SF Global Physical Health Raw Assessment Score
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56.1 score on a scale
Standard Deviation 9.43
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Quality of Life After Mesh Implantation
Day 30 PROMIS SF Global Mental Health Raw Assessment Score
|
50.73 score on a scale
Standard Deviation 9.89
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SECONDARY outcome
Timeframe: 30 days, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Intervention
n=4 Participants
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
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|---|---|
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Bowel Function After Mesh Implantation
30 days, raw data score
|
16.83 score on a scale
Standard Deviation 5.23
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Adverse Events
Intervention
Serious adverse events
| Measure |
Intervention
n=8 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
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12.5%
1/8 • Number of events 1 • 30 days.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place