An interventional study of High-Purity Type I Collagen Mesh in Hernia, Ventral Hernia and Incisional Hernia, sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. Completed at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara · Not applicable, Interventional, and Treatment
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.
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.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →Adichunchanagiri Institute of Medical Sciences, B G Nagara is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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.
Time frame: Up to 8 weeks post-operatively
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.
Time frame: Up to 8 weeks
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.
Time frame: Baseline (preoperatively) to 8 weeks postoperatively
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: 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.
Time frame: Up to 8 weeks
Length of Hospital Stay
Number of postoperative inpatient days
Time frame: From immediately after the surgery until hospital discharge
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
Time frame: 8 weeks post-operatively
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)
Time frame: Baseline and 8 weeks post-operatively
| Milestone | HPTC-Reinforced Hernia Repair |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Incidence (number of participants) of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks postoperatively.
| Participants | HPTC-Reinforced Hernia Repair |
|---|---|
| Superficial Surgical Site Infection | 4 |
| Deep Surgical Site Infection | 0 |
| Mesh explantation | 0 |
| Collagen adverse events | 0 |
| Reoperation | 0 |
Incidence (number of participants) of wound complications including seroma, hematoma, and wound dehiscence within 8 weeks postoperatively.
| Participants | HPTC-Reinforced Hernia Repair |
|---|---|
| Seroma requiring aspiration | 2 |
| Hematoma | 0 |
| Wound dehiscence | 0 |
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.
| score on a scale | HPTC-Reinforced Hernia Repair |
|---|---|
| Baseline | 6.0 ± 1.1 |
| 2 weeks | 4.1 ± 1.2 |
| 4 weeks | 3.4 ± 1.1 |
| 8 weeks | 2.9 ± 1.0 |
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.
| Participants | HPTC-Reinforced Hernia Repair |
|---|---|
| Intact repair | 30 |
| Fascial dehiscence | 0 |
| Clinical bulge | 0 |
| Early recurrence | 0 |
Number of postoperative inpatient days
| days | HPTC-Reinforced Hernia Repair |
|---|---|
| Length of Hospital Stay | 3.2 ± 1.4 |
Patient-reported satisfaction with surgical outcome assessed on a 5-point Likert scale: Very satisfied / Satisfied / Neutral / Dissatisfied / Very dissatisfied
| Participants | HPTC-Reinforced Hernia Repair |
|---|---|
| Very satisfied | 16 |
| Satisfied | 11 |
| Neutral | 3 |
| Dissatisfied | 0 |
| Very dissatisfied | 0 |
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)
| score on a scale | HPTC-Reinforced Hernia Repair |
|---|---|
| Baseline | 42 ± 12 |
| 8 weeks | 21 ± 9 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HPTC-Reinforced Hernia Repair | 0/30 (0%) | 0/30 (0%) | 4/30 (13.3%) |
| Event | HPTC-Reinforced Hernia Repair |
|---|---|
| Mesh infectionInfections and infestations | 0/30 |
| Hospital readmissionSurgical and medical procedures | 0/30 |
| ReoperationSurgical and medical procedures | 0/30 |
| Event | HPTC-Reinforced Hernia Repair |
|---|---|
| Superficial SSIInfections and infestations | 4/30 |
| Seroma requiring aspirationSkin and subcutaneous tissue disorders | 2/30 |
| Age, Continuous(years) | HPTC-Reinforced Hernia Repair |
|---|---|
| Mean | 55.2 ± 10.6 |
| Sex: Female, Male(Participants) | HPTC-Reinforced Hernia Repair |
|---|---|
| Female | 9 |
| Male | 21 |
| Race and Ethnicity Not Collected(Participants) | HPTC-Reinforced Hernia Repair |
|---|
| Region of Enrollment(participants) | HPTC-Reinforced Hernia Repair |
|---|---|
| India | 30 |
| Hernia Type(Participants) | HPTC-Reinforced Hernia Repair |
|---|---|
| Ventral / Incisional | 22 |
| Inguinal | 8 |
| Risk Factors(Participants) | HPTC-Reinforced Hernia Repair |
|---|---|
| Recurrent hernia | 14 |
| Diabetes mellitus | 11 |
| Obesity (BMI ≥30) | 9 |
| Contaminated field | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data underlying the results reported in this clinical study will be made available upon reasonable request. Shared data will include baseline characteristics, peri-operative variables, postoperative outcomes, and patient-reported outcome measures collected during the 8-week follow-up period. All shared data will be fully anonymized, with no direct or indirect identifiers.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years thereafter.
Access criteria: Access to de-identified IPD will be granted to qualified researchers upon submission of: A methodologically sound research proposal Intended use aligned with scientific and ethical standards Requests will be reviewed by the study investigators. Data will be shared under a data use agreement to ensure appropriate use and protection of participant confidentiality.
Ran from Jan 2026 to primary completion in Mar 2026, 2 months.
Results were first posted in Apr 2026, 1 month after primary completion.
Of 50 non-industry interventional studies with no phase under Hernia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's 2 months is below that.
Counting every sponsor, half of 57 studies reached it within 33 months; a quarter within 16 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Adichunchanagiri Institute of Medical Sciences, B G Nagara