Early Clinical Outcomes of High-Purity Type I Collagen as a Biologic Reinforcement in Selected Hernia Repair Scenarios: A Prospective Clinical Study
Phase: NA
Conditions: Hernia, Ventral Hernia, Incisional Hernia, İnguinal Hernia, Abdominal Wall Hernia, Surgical Site Infection, Postoperative Complications
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara

Title: Prospective Clinical Evaluation of High-Purity Type I Collagen in Select 
High-Risk Hernia Repair Scenarios 
 
 
NCT No: NCT07360691 
 
 
Date: March 16, 2026 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

INTRODUCTION 
Hernia repair is among the most frequently performed general surgical procedures 
worldwide, with synthetic mesh reinforcement significantly reducing recurrence rates 
compared with primary suture repair alone [1,2]. Despite these advances, mesh-related 
complications such as surgical site infection, chronic inflammation, mesh extrusion, 
persistent pain, and the need for mesh explantation continue to pose substantial clinical 
challenges [3–5]. These issues are particularly pronounced in contaminated or potentially 
contaminated fields and in patients with multiple comorbidities, where permanent synthetic 
mesh implantation may exacerbate morbidity [6,7]. 
Synthetic meshes function as permanent foreign bodies and may provoke prolonged 
inflammatory responses, fibrosis, and bacterial biofilm formation. In high-risk settings such 
as emergency hernia repair, re-operative abdominal wall surgery, diabetes, obesity, smoking, 
immunosuppression, and prior mesh infection, the risk of postoperative complications is 
significantly increased [4–7]. Consequently, surgeons often face a dilemma between 
accepting higher recurrence rates with suture repair and the potential morbidity associated 
with synthetic mesh placement. 
Biologic meshes have emerged as selective alternatives in such complex scenarios. These 
materials, typically derived from collagen-rich extracellular matrices, are designed to provide 
temporary structural support while facilitating host tissue integration, angiogenesis, and 
gradual remodelling [8–10]. Compared with permanent synthetic meshes, biologic scaffolds 
demonstrate reduced inflammatory response and greater resistance to infection, making them 
attractive adjuncts in contaminated or high-risk operative fields [9,10]. However, variability 
in source tissue, processing techniques, cross-linking, and degradation profiles has resulted in 
heterogeneous clinical outcomes, limiting their widespread adoption [8]. 
High-purity type I collagen (HPTC), marketed as Surgicoll-Mesh®, is a bioengineered 
collagen scaffold composed of more than 97% native type I collagen. It is manufactured 
using proprietary purification processes that remove immunogenic proteins, elastin, and lipids 
while preserving the native triple-helical collagen structure [11,12]. Unlike heavily cross-
linked biologic meshes, HPTC remains un-crosslinked and resorbable, allowing controlled 
enzymatic degradation and progressive replacement by organized host tissue rather than 
persistent foreign material. 
The regenerative and anti-inflammatory properties of high-purity type I collagen have been 
demonstrated across multiple clinical applications. Prospective studies and randomized 

controlled trials have reported improved tissue quality, accelerated healing, reduced 
inflammation, and favourable safety profiles in chronic wounds, venous leg ulcers, diabetic 
foot ulcers, and complex reconstructive settings [13–16]. These findings suggest that HPTC 
functions not merely as a passive scaffold but as a biologically active matrix capable of 
modulating the healing microenvironment. 
In the context of abdominal wall reconstruction, early clinical reports have suggested that 
collagen-based meshes may be particularly useful as biologic reinforcement in infected or 
high-risk hernia repairs, facilitating wound resolution and tissue integration while minimizing 
mesh-related morbidity [9,10,17]. However, much of the existing evidence is retrospective, 
heterogeneous, and limited by small sample sizes, underscoring the need for prospective 
evaluation using standardized outcome measures. 
Feasibility and early-outcome studies play a critical role in the clinical evaluation of biologic 
materials intended for adjunctive use. Such studies allow systematic assessment of safety, 
handling characteristics, wound behavior, and short-term clinical outcomes while avoiding 
overinterpretation of efficacy [18]. They also provide essential data on outcome variability 
and procedural practicality that inform the design of future comparative or randomized trials. 
The present prospective, single-arm clinical study was therefore designed to evaluate the 
early safety, feasibility, and short-term clinical outcomes of high-purity type I collagen used 
as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic 
mesh placement is considered undesirable. The study focuses on early postoperative 
outcomes, including wound healing, surgical site infection, pain trajectory, and short-term 
integrity of repair, with the aim of generating hypothesis-generating data to guide future 
controlled investigations. 
 
 
 
 
 
 
 
 
 
 

MATERIALS AND METHODS 
Study Design and Setting 
This study was designed as a prospective, single-arm clinical study evaluating the early 
safety, feasibility, and short-term clinical outcomes of high-purity type I collagen (HPTC; 
Surgicoll-Mesh®) used as a biologic reinforcement in selected hernia repair scenarios. The 
study was conducted at a tertiary care teaching hospital with experience in complex 
abdominal wall reconstruction and biologic mesh application. 
The study design and operative principles were informed by the authors previously published 
clinical experience using high-purity type I collagen in infected and high-risk hernia 
scenarios, which demonstrated favourable wound outcomes and acceptable early durability in 
a retrospective case series [19]. The present study was undertaken to prospectively evaluate 
early outcomes using standardized inclusion criteria, outcome measures, and follow-up 
protocols. 
Institutional Ethics Committee approval was obtained prior to patient enrolment. All 
procedures were conducted in accordance with the Declaration of Helsinki and Good Clinical 
Practice guidelines. Written informed consent was obtained from all participants after 
explaining the nature of the biologic material, its intended role as reinforcement, and the 
scope of early outcome evaluation. 
 
Patient Selection 
Adult patients aged 18 to 75 years undergoing elective or semi-elective hernia repair were 
screened for eligibility. Inclusion was restricted to clinical scenarios in which permanent 
synthetic mesh placement was considered undesirable due to local or systemic risk factors. 
These included patients with contaminated or potentially contaminated surgical fields 
(Centers for Disease Control wound class II or III), prior mesh infection or explantation, 
recurrent hernia with compromised soft tissue, diabetes mellitus, obesity, smoking history, 
immunosuppression, or advanced age with poor tissue quality. 
Hernia types included ventral, incisional, and selected inguinal hernias where biologic 
reinforcement was deemed appropriate by the operating surgeon. Patients with active 
generalized sepsis, gross faecal contamination, loss of abdominal domain requiring staged 
reconstruction, known hypersensitivity to collagen, pregnancy, malignancy involving the 
abdominal wall, or inability to comply with postoperative follow-up were excluded. 
 

Surgical Technique and Application of High-Purity Type I Collagen 
All procedures were performed under general or regional anesthesia using standard aseptic 
technique. Hernia repair was undertaken using established principles of tension-free closure, 
with primary fascial approximation wherever feasible. Limited component separation 
techniques were employed when required to achieve midline closure without undue tension. 
High-purity type I collagen mesh was prepared according to manufacturer instructions and 
hydrated in sterile saline prior to implantation. The collagen scaffold was used strictly as a 
biologic reinforcement and not as a bridging material. Depending on defect location and 
surgeon preference, the mesh was placed in an onlay or sublay position, ensuring complete 
coverage of the repaired fascial defect with adequate overlap onto healthy tissue. 
The collagen mesh was secured using interrupted or continuous absorbable sutures, taking 
care to avoid excessive tension or folding. Particular attention was paid to achieving intimate 
contact between the mesh and host tissue to facilitate cellular infiltration and integration. 
Closed-suction drains were placed selectively based on wound characteristics and removed 
according to standard clinical criteria. Skin closure was performed in layers. 
 
Postoperative Care and Follow-Up 
Postoperative management followed institutional protocols, including appropriate antibiotic 
coverage based on wound classification and comorbid risk factors. Patients were encouraged 
to ambulate early and were advised to avoid heavy lifting for a minimum of six weeks. 
Wound assessments were performed during inpatient stay and at scheduled outpatient visits. 
Clinical follow-up was conducted at two weeks, four weeks, and eight weeks postoperatively. 
These time points were selected to capture early wound behaviour, pain trajectory, and 
immediate postoperative complications, consistent with feasibility and early-outcome study 
objectives. 
 
Outcome Measures 
The primary outcomes of interest were safety and feasibility, defined by successful 
implantation of the collagen mesh, absence of intraoperative technical difficulty, and absence 
of collagen-related adverse events. Secondary early clinical outcomes included surgical site 
infection, wound seroma or dehiscence, postoperative pain assessed using the Visual Analog 
Scale, and early clinical integrity of repair assessed by physical examination. 
Outcomes were recorded prospectively using standardized case record forms. Surgical site 
infections were classified according to Centres for Disease Control criteria. 

Statistical Analysis Plan 
Given the exploratory nature of this early-outcomes study, no formal sample size calculation 
for efficacy was performed. Continuous variables were summarized as mean ± standard 
deviation or median with interquartile range, depending on data distribution. Categorical 
variables were expressed as frequencies and percentages. 
Changes in pain scores over time were analysed using paired t-tests or Wilcoxon signed-rank 
tests, as appropriate. Statistical significance was defined conservatively as p < 0.05. All 
analyses were considered exploratory and hypothesis-generating. Statistical analysis was 
performed using standard statistical software.