Evidence map›Paper›PMID 40062152›Full record

ArticleCureus2025

Real-World Evaluation of the Safety and Efficacy of Surgi-ORC® in Orthopedic Surgeries: A Multicenter Prospective Study.

Piyush Patel, Diksha Sharma, Bhavin Trivedi, Shahid Karatela

Abstract read
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Piyush PatelQuality, Aegis Lifesciences Pvt. Ltd., Ahmedabad, IND.
Diksha SharmaResearch and Development, Aegis Lifesciences Pvt. Ltd., Ahmedabad, IND.
Bhavin TrivediRegulatory Affairs, Aegis Lifesciences Pvt. Ltd., Ahmedabad, IND.
Shahid KaratelaRegulatory Affairs and Quality Assurance, Aegis Lifesciences Pvt. Ltd., Ahmedabad, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aim Achieving adequate hemostasis is a critical aspect of surgical practice, especially in orthopedics, where bleeding can impact visibility and patient outcomes. Surgi-ORC® (Aegis Lifesciences Pvt. Ltd., Ahmedabad, India), an oxidized regenerated cellulose hemostatic agent, was evaluated for its safety, efficacy, biocompatibility, and clinical performance in real-world patients undergoing orthopedic surgeries. Method This prospective observational study included patients undergoing upper limb, lower limb, or axial skeletal orthopedic surgeries. Blood loss, time to hemostasis (TTH), and surgeon-rated performance parameters such as ease of application, conformation to tissue, and preparation were recorded to assess the performance of Surgi-ORC® at predefined time points. Biocompatibility assessments were conducted through in vitro and in vivo tests, including reactivity, sensitization, systemic toxicity, tissue response, and hemolytic potential. Results The study involved 59 patients undergoing orthopedic surgeries using Surgi-ORC® variants: Powder (n=4), Knit (n=5), Original/Standard (n=4), Fibril (n=42), and Non-Woven/Snow (n=4). Hemostasis was achieved in 100% of cases within ≤ five minutes, with a mean TTH of 1.95 minutes (Surgi-ORC® Original/Standard). Powder demonstrated the lowest mean TTH across all surgeries, averaging 0.83 to 1.08 minutes. Surgeon feedback highlighted excellent handling, ease of application, and conformance to tissue without sticking/adherence to surgical gloves/surgical instruments. No infections, adverse events, or complications occurred over 60 days, and all patients showed stable recoveries. The surgeon confirmed complete absorption by day two.  Conclusion Surgi-ORC® is a reliable and effective hemostatic agent for orthopedic surgeries. Its ease of use, handling characteristics, ease of placing, stability upon placement, and safety profile make it a preferred choice among surgeons.

Indexed as

haemostasisorthopedic surgeryoxidized regenerated cellulose (orc)surgi-orc® fibrilsurgi-orc® non-woven/snowsurgi-orc® originalsurgi-orc® powdersurgi-orc® standard

Identifiers

PMID40062152
PMCPMC11889987

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.