Abdominal Wall Hernia, Hernia, Incisional Hernia, İnguinal Hernia, Postoperative Complications, Surgical Site Infection, Ventral Hernia
Conditions
Keywords
Hernia Repair, Ventral Hernia Repair, Incisional Hernia Repair, Inguinal Hernia Repair, Biological Mesh, Type I Collagen, Wound Healing, Postoperative Pain, Hernia Recurrence
Brief summary
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.
Detailed description
Synthetic mesh has reduced hernia recurrence but is associated with significant complications in contaminated fields and high-risk patients. Biologic meshes offer potential advantages including biocompatibility, resistance to infection, and tissue remodeling. High-Purity Type I Collagen (\>97% purity) is an un-crosslinked, resorbable scaffold designed to support host tissue integration. This prospective observational study systematically evaluates early clinical outcomes following HPTC-reinforced hernia repair, including surgical site infection, wound healing, postoperative pain, and early integrity of repair. The study is not designed to assess long-term recurrence.
Interventions
DEVICEHigh-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.
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Ventral, incisional, umbilical, or para-umbilical hernia * Contaminated or potentially contaminated surgical field * Hernia repair following infected mesh explantation * High-risk patients (diabetes, obesity, smoking, immunosuppression) * Ability to provide informed consent
Exclusion criteria
* Clean, low-risk primary hernia suitable for synthetic mesh * Large defects requiring permanent load-bearing prosthesis * Generalized peritonitis or uncontrolled sepsis * Known collagen hypersensitivity * Pregnancy * Inability to comply with follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation) | Up to 8 weeks post-operatively | Incidence (number of participants) of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Wound Complications (Seroma, Hematoma, or Wound Dehiscence) | Up to 8 weeks | Incidence (number of participants) of wound complications including seroma, hematoma, and wound dehiscence within 8 weeks postoperatively. |
| Postoperative Change in Visual Analog Scale (VAS) Pain Scores | Baseline (preoperatively) to 8 weeks postoperatively | 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. |
| Early Clinical Integrity of Repair | Up to 8 weeks | Clinical integrity of repair assessed by standardized postoperative clinical examination at scheduled follow-up visits (2, 4, and 8 weeks). Definitions: 1. Intact repair: No evidence of fascial separation, wound disruption, or abnormal protrusion on inspection and palpation. 2. Fascial dehiscence: Partial or complete separation of the fascial closure identified clinically. 3. Clinical bulge: Localized protrusion at the repair site without confirmed fascial defect, detected on standing or straining examination. 4. 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. |
| Length of Hospital Stay | From immediately after the surgery until hospital discharge | Number of postoperative inpatient days |
| Patient Satisfaction With Hernia Repair | 8 weeks post-operatively | Patient-reported satisfaction with surgical outcome assessed on a 5-point Likert scale: Very satisfied / Satisfied / Neutral / Dissatisfied / Very dissatisfied |
| Hernia-Specific Quality of Life | Baseline and 8 weeks post-operatively | 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) |
Countries
India
Contacts
STUDY_CHAIRPrema Dhanraj, MS, MCh
Rajarajeshwari Medical College and Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 10.6 |
| Hernia Type Inguinal | 8 Participants |
| Hernia Type Ventral / Incisional | 22 Participants |
| Region of Enrollment India | 30 participants |
| Risk Factors Contaminated field | 10 Participants |
| Risk Factors Diabetes mellitus | 11 Participants |
| Risk Factors Obesity (BMI ≥30) | 9 Participants |
| Risk Factors Recurrent hernia | 14 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed