| Primary | Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation) | Incidence (number of participants) of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks postoperatively. | | Posted | | Count of Participants | | Participants | | Up to 8 weeks post-operatively | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
| | | Title | Denominators | Categories |
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| Superficial Surgical Site Infection | | | | Deep Surgical Site Infection | | | | Mesh explantation | | |
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| Secondary | Number of Participants With Early Wound Complications (Seroma, Hematoma, or Wound Dehiscence) | Incidence (number of participants) of wound complications including seroma, hematoma, and wound dehiscence within 8 weeks postoperatively. | | Posted | | Count of Participants | | Participants | | Up to 8 weeks | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
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| Secondary | Postoperative Change in Visual Analog Scale (VAS) Pain Scores | Change in pain intensity assessed using the Visual Analog Scale for Pain, a patient-reported numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse pain intensity. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (preoperatively) to 8 weeks postoperatively | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
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| Secondary | Early Clinical Integrity of Repair | Clinical integrity of repair assessed by standardized postoperative clinical examination at scheduled follow-up visits (2, 4, and 8 weeks). Definitions:
- Intact repair: No evidence of fascial separation, wound disruption, or abnormal protrusion on inspection and palpation.
- Fascial dehiscence: Partial or complete separation of the fascial closure identified clinically.
- Clinical bulge: Localized protrusion at the repair site without confirmed fascial defect, detected on standing or straining examination.
- Early recurrence: Reappearance of a hernia defect at or adjacent to the repair site confirmed on clinical examination within 8 weeks.
All assessments were performed by the treating surgical team using standardized clinical evaluation. | | Posted | | Count of Participants | | Participants | | Up to 8 weeks | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
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| Secondary | Length of Hospital Stay | Number of postoperative inpatient days | | Posted | | Mean | Standard Deviation | days | | From immediately after the surgery until hospital discharge | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
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| Secondary | Patient Satisfaction With Hernia Repair | Patient-reported satisfaction with surgical outcome assessed on a 5-point Likert scale: Very satisfied / Satisfied / Neutral / Dissatisfied / Very dissatisfied | | Posted | | Count of Participants | | Participants | | 8 weeks post-operatively | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
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| Secondary | Hernia-Specific Quality of Life | Hernia-specific quality of life assessed using European Registry for Abdominal Wall Hernias Quality of Life Score (EuraHS-QoL), covering: Pain at rest and during activity, Restriction of activities, Cosmetic discomfort. Scores range from 0 (no impairment) to 90 (worst impairment) | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and 8 weeks post-operatively | | | | ID | Title | Description |
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| OG000 | HPTC-Reinforced Hernia Repair | Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios. High-Purity Type I Collagen Mesh: High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk. |
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