A Randomized Controlled Trial Evaluating High-Purity Type I Collagen Wrap Around Extensor Tendon Repair Sites in Zones VI-VIII of the Hand to Prevent Adhesions and Improve Functional Outcomes
Sponsor study identifier
interventional
60
1 country
2
Study Start
December 5, 2025
Actual (reported)Primary Completion
February 21, 2026
Actual (reported)Study Completion
February 26, 2026
Actual (reported)Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane can reduce adhesion formation and improve functional outcomes compared with standard repair alone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 26, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2025
Actual (reported)January 2, 2026
Actual (reported)January 13, 2026
Actual (reported)February 21, 2026
Actual (reported)February 26, 2026
Actual (reported)April 13, 2026
Actual (reported)Total Active Motion (TAM) of Involved Finger(s)
Total Active Motion (TAM) is calculated as the sum of active flexion at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints minus the extension deficits. TAM is expressed in degrees. Higher values indicate better functional outcome.
8 weeks postoperatively
QuickDASH Score
6 weeks and 8 weeks postoperatively
Extensor Lag
8 weeks postoperatively
Number of Participants With Clinically Significant Tendon Adhesions
Up to 8 weeks postoperatively
Grip Strength
8 weeks postoperatively
Time to Return to Work or Activities of Daily Living
Up to 8 weeks postoperatively
After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448, India
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001, India
15. Wong JKF, Metcalfe AD, Wong R, Bush J, Platt C, McGrouther DA. Reduction of tendon adhesion formation with a collagen-GAG scaffold: an experimental study. J Hand Surg Eur Vol. 2006;31(2):143-150.
Moran SL, Ryan CK, Orlando GS, Ehara K, Hentz VR. Effects of anti-adhesion barriers on the healing of repaired extensor digitorum communis tendons in a rabbit model. J Hand Surg Am. 2000;25(3):546-553.
Narayan N, Raghupathi D, Ramamurthy V, Chethan S, Gowda S. A Comparative Analysis in the Treatment of Full-Thickness Wounds: Negative-Pressure Wound Therapy (NPWT) Combined With High-Purity Type I Collagen-Based Skin Substitute Versus NPWT Alone. Cureus. 2025 Nov 16;17(11):e96977. doi: 10.7759/cureus.96977. eCollection 2025 Nov.
The follow-up period was limited to eight weeks, which may not fully capture long-term tendon gliding, late adhesion formation, or need for secondary procedures such as tenolysis.
Prema Dhanraj, MS, MCh
Rajarajeshwari Medical College and Hospital
60 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2026
First Posted
January 13, 2026
Study Start
December 5, 2025
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.
Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.
Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
Wong JK, Lui YH, Kapacee Z, Kadler KE, Ferguson MW, McGrouther DA. The cellular biology of flexor tendon adhesion formation: an old problem in a new paradigm. Am J Pathol. 2009 Nov;175(5):1938-51. doi: 10.2353/ajpath.2009.090380. Epub 2009 Oct 15.
Al-Qattan MM. Controlled active motion following extensor tendon repair in zones V-VIII. J Hand Surg Br. 2005;30(2):166-169.
VERDAN CE. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960 Jun;42-A:647-57. No abstract available.
Newport ML, Blair WF, Steyers CM Jr. Long-term results of extensor tendon repair. J Hand Surg Am. 1990 Nov;15(6):961-6. doi: 10.1016/0363-5023(90)90024-l.
Primary Completion
February 21, 2026
Actual (reported)Study Completion
February 26, 2026
Actual (reported)Last Updated
April 13, 2026
Results First Posted
April 13, 2026
Record last verified: 2026-03
De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be shared. This includes demographic variables, injury characteristics, intervention allocation, Total Active Motion (TAM) measurements, QuickDASH scores, extensor lag measurements, grip strength values, complication data, and time-to-return-to-work variables. Data dictionaries and metadata necessary to interpret the shared datasets will also be provided.
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Source: ClinicalTrials.gov.
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