Clinical Validation
Clinical Evidence
The Shira 3-Jaw Microvascular Clamp has been independently evaluated in three peer-reviewed publications across institutions in India and the United States. Each study consistently demonstrates reduced anastomosis time, elimination of backwalling, and a measurably shallower learning curve versus standard Acland clamps.
(vs 30.8% Acland)
improvement (RCT)
of evidence
Evidence Summary — Across All Three Studies
| Outcome | Finding | Best p-value |
|---|---|---|
| Anastomosis time | Significantly reduced vs Acland across all three studies | p < 0.001 |
| Backwalling / improper bites | 0% with Shira vs 30.8% with Acland | — |
| Posterior wall access | No clamp flip required in any case — confirmed across all studies | — |
| Clamp flip required | 0% with Shira vs 38.5% with Acland | — |
| Ease of use rating | Significantly higher surgeon rating with Shira | p < 0.001 |
| Need for assistance | Significantly lower with Shira clamp | p < 0.001 |
| Highest study level achieved | Randomized Controlled Trial (AIIMS Jodhpur, 2023) | — |
Full Publication Details
Novel Microvascular Clamps to Aid Trainee Surgeon Education: Smarter Than Acland Micro Clamps?
DOI: 10.1097/PRS.0000000000009530 · PMID: 35960914 · Published in Plastic and Reconstructive Surgery — flagship journal of the American Society of Plastic Surgeons
Study Design & Key Results
10 plastic surgery trainees (6–24 months of microsurgery training) performed 25 vascular anastomoses — 12 with the Shira 3-Jaw clamp, 12 with standard Acland clamps — during live free flap and flexor tendon repair procedures.
0%
Backwalling / improper bites with Shira vs 30.8% with Acland
0%
Clamp flipping needed with Shira vs 38.5% with Acland
p = 0.007
Anastomosis time significantly shorter with Shira
p < 0.001
Need for surgical assistance significantly lower with Shira
A novel, innovative clamp with vessel eversion feature for end-to-end microvascular anastomosis
DOI: 10.1016/j.bjps.2022.06.068 · PMID: 35851497
Key Findings
First
Clinical report of 3-jaw vessel eversion design in microvascular reconstruction
Full
Posterior wall visibility achieved without repositioning or flipping the clamp
21.7%
Backwalling rate with Acland — directly eliminated by Shira's eversion mechanism
19.6%
Incomplete bite rate with Acland — eliminated by full lumen visibility under Shira clamp
"The device achieves vessel eversion and maintains the vessel wall open under occlusion, providing unobstructed visualization of the posterior wall without the need for clamp repositioning."
— Authors, JPRAS 2022Efficacy of novel, three jaw adventitia holding microclamps compared to Acland microclamps in patients undergoing end-to-end microvascular anastomosis: A randomized control trial
DOI: 10.1016/j.bjps.2023.09.022 · PMID: 37812846
Study Design
Single-centre, parallel-group randomized clinical trial. 30 patients, 1:1 allocation — TADH (3-Jaw) clamp group vs Acland clamp group. Primary outcome: arterial and venous clamping and suturing time. Secondary outcomes: ease of use, need for clamp flipping, need for assistance, flap survival.
p < 0.001
Artery clamp + suture time significantly faster with 3-Jaw
p < 0.001
Vein clamp + suture time significantly faster with 3-Jaw
0
Clamp flips required with 3-Jaw in any case throughout the entire trial
p < 0.001
Ease of use significantly higher with 3-Jaw (Chi-square 9.867)
p < 0.001
Need for assistance significantly lower with 3-Jaw (Chi-square 19.286)
"This study found TADH microclamps to be faster, easier to use, and clinically efficacious in reducing the anastomosis time compared to those of the Acland clamps."
— Authors' conclusion, JPRAS 2023 RCTNeed full-text documentation?
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