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| Name | Class |
|---|---|
| Mysore Medical College and Research Institute | OTHER |
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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.
Extensor tendon injuries of the hand are common due to the superficial location of the tendons and the thin soft tissue envelope over the dorsum of the hand and wrist. These injuries, particularly in zones VI-VIII, are frequently associated with postoperative adhesions and extensor lag, leading to functional impairment and delayed return to work. Postsurgical adhesions may occur in up to 30-40% of tendon injuries and remain a major clinical challenge despite advances in suture techniques and rehabilitation protocols.
Several strategies have been investigated to minimize tendon adhesions, including optimized suture techniques, early mobilization, anti-adhesive agents, and biologic barrier membranes. Recent clinical work has shown that wrapping repaired extensor tendons with an amniotic membrane in zone VI can improve range of motion (ROM), Quick DASH scores, and recovery time, suggesting a true reduction in peritendinous fibrosis. Experimental models have also demonstrated that collagen-glycosaminoglycan (GAG) wraps can reduce early postoperative tendon adhesions while preserving tendon healing strength.
HPTC is a bioengineered, acellular dermal replacement product composed of >97% pure Type I collagen, free of elastin, lipids, and immunogenic proteins. It is manufactured to preserve the native triple helical structure and bioactivity of collagen, providing a cell-conducive scaffold that promotes neovascularization, granulation tissue formation, and tissue remodelling. HPTC is flexible, translucent, moderately tacky, and can be cut, sutured or stapled, making it feasible to be fashioned as a wrap or sleeve around tendons.
Multiple randomized controlled trials and clinical series by Narayan et al. have demonstrated the safety and efficacy of high-purity Type I collagen-based skin substitute HPTC in chronic and acute wounds.
These studies collectively show that high-purity Type I collagen membranes are safe, well tolerated, promote faster wound healing, and have favourable scarring and pain profiles in a variety of clinical settings.
Rationale for the Current Study - Given the strong biological plausibility of Type I collagen scaffolds as biocompatible, resorbable barriers that can modulate the healing milieu; the safety and clinical efficacy of HPTC in multiple wound types; and the demonstrated benefit of biologic wraps (e.g., amniotic membrane) around extensor tendon repairs in reducing adhesions, it is logical to evaluate whether a HPTC wrap around the repaired extensor tendon in zones VI-VIII can reduce adhesion-related stiffness and improve functional outcomes compared with standard repair alone.
This trial will be, to our knowledge, the first prospective randomized clinical trial to assess HPTC as a tendon wrap in extensor tendon repairs of the hand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPTC Wrap + Standard Extensor Tendon Repair | Active Comparator | 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. |
|
| Standard Extensor Tendon Repair Alone | Other | Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Purity Type I Collagen (HPTC) Wrap | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QuickDASH Score | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire assessing upper limb disability and symptoms. Lower scores indicate better function. Higher scores indicate greater impairment. Score Range 0 to 100. | 6 weeks and 8 weeks postoperatively |
| Extensor Lag |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prema Dhanraj, MS, MCh | Rajarajeshwari Medical College and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adichunchanagiri Institute of Medical Sciences | Mandya | Karnataka | 571448 | India | ||
| Mysore Medical College and Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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. | ||
| 41250786 | Background | 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. | |
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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.
IPD will be available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years following publication.
IPD will be shared with qualified researchers who submit a methodologically sound research proposal and agree to the terms of data use.
IPD may be used for meta-analyses, secondary analyses, methodological research, or validation studies related to tendon repair outcomes and adhesion prevention strategies.
Data will be shared upon reasonable request through secure institutional data-sharing platforms or encrypted electronic transfer after execution of a data use agreement (DUA). All shared data will be fully de-identified to protect participant confidentiality, in accordance with applicable ethical and regulatory guidelines.
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| ID | Title | Description |
|---|---|---|
| FG000 | HPTC Wrap + Standard Extensor Tendon Repair | 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. High-Purity Type I Collagen (HPTC) Wrap: 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. Standard Extensor Tendon Repair: Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2026 |
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| Standard Extensor Tendon Repair | Procedure | Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
|
Extensor lag was calculated as the total extension deficit (in degrees) across the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints of the involved finger(s). The deficits at each joint were summed to generate a single total extensor lag value. Lower values indicate better functional outcome. |
| 8 weeks postoperatively |
| Number of Participants With Clinically Significant Tendon Adhesions | Number of participants who developed clinically significant tendon adhesions within 8 weeks postoperatively. Clinically significant adhesion was defined as failure to achieve Total Active Motion (TAM) ≥60% of the contralateral digit despite adherence to rehabilitation protocol and/or requirement for surgical tenolysis. Higher values indicate greater frequency of adhesion-related complications. | Up to 8 weeks postoperatively |
| Grip Strength | Grip strength measured using a calibrated Jamar dynamometer and expressed as a percentage of the contralateral uninvolved side. Higher values indicate better functional recovery. | 8 weeks postoperatively |
| Time to Return to Work or Activities of Daily Living | Number of days from surgery to return to pre-injury occupational or activities of daily living status. | Up to 8 weeks postoperatively |
| Patient Satisfaction | Patient-reported satisfaction with hand function and appearance measured using Likert scale. Scale range: 1 to 10 (1 = very dissatisfied, 10 = very satisfied). Interpretation: Higher scores indicate greater patient satisfaction. | 8 weeks postoperatively |
| Mysore |
| Karnataka |
| 570001 |
| India |
| Background |
| 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. |
| 40862036 | Background | 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. |
| 40747200 | Background | 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. |
| 19834058 | Background | 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. |
| Background | Al-Qattan MM. Controlled active motion following extensor tendon repair in zones V-VIII. J Hand Surg Br. 2005;30(2):166-169. |
| 13855215 | Background | VERDAN CE. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960 Jun;42-A:647-57. No abstract available. |
| 2269792 | Background | 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. |
| FG001 | Standard Extensor Tendon Repair Alone | Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. Standard Extensor Tendon Repair: Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HPTC Wrap + Standard Extensor Tendon Repair | 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. High-Purity Type I Collagen (HPTC) Wrap: 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. Standard Extensor Tendon Repair: Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
| BG001 | Standard Extensor Tendon Repair Alone | Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. Standard Extensor Tendon Repair: Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/Ethnicity of Participants | Count of Participants | Participants |
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| Region of Enrollment | Country where participants were recruited and enrolled in the trial. | Count of Participants | Participants |
| |||||||||||||||||
| Injury Zone | Injury location classified according to Verdan's anatomical classification of extensor tendons of the hand and wrist, based on the site of tendon laceration: Zone VI: Dorsum of the hand over the metacarpals. Zone VII: Region of the wrist corresponding to the extensor retinaculum. Zone VIII: Distal forearm proximal to the extensor retinaculum involving musculotendinous junctions. Injuries in higher zones (e.g. Zone VIII) are generally associated with more complex anatomy, involvement of musculotendinous units, and potentially more challenging rehabilitation compared to lower zones (Zone VI) | Count of Participants | Participants |
| |||||||||||||||||
| Injury Complexity | Extent of injury categorized by the number of extensor tendons involved in the repair (single tendon vs multiple tendons). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | degrees | 8 weeks postoperatively |
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| Secondary | QuickDASH Score | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire assessing upper limb disability and symptoms. Lower scores indicate better function. Higher scores indicate greater impairment. Score Range 0 to 100. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks and 8 weeks postoperatively |
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| Secondary | Extensor Lag | Extensor lag was calculated as the total extension deficit (in degrees) across the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints of the involved finger(s). The deficits at each joint were summed to generate a single total extensor lag value. Lower values indicate better functional outcome. | Posted | Mean | Standard Deviation | degrees | 8 weeks postoperatively |
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| Secondary | Number of Participants With Clinically Significant Tendon Adhesions | Number of participants who developed clinically significant tendon adhesions within 8 weeks postoperatively. Clinically significant adhesion was defined as failure to achieve Total Active Motion (TAM) ≥60% of the contralateral digit despite adherence to rehabilitation protocol and/or requirement for surgical tenolysis. Higher values indicate greater frequency of adhesion-related complications. | Posted | Count of Participants | Participants | Up to 8 weeks postoperatively |
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| Secondary | Grip Strength | Grip strength measured using a calibrated Jamar dynamometer and expressed as a percentage of the contralateral uninvolved side. Higher values indicate better functional recovery. | Posted | Mean | Standard Deviation | percentage of contralateral side | 8 weeks postoperatively |
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| Secondary | Time to Return to Work or Activities of Daily Living | Number of days from surgery to return to pre-injury occupational or activities of daily living status. | Posted | Mean | Standard Deviation | weeks | Up to 8 weeks postoperatively |
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| Secondary | Patient Satisfaction | Patient-reported satisfaction with hand function and appearance measured using Likert scale. Scale range: 1 to 10 (1 = very dissatisfied, 10 = very satisfied). Interpretation: Higher scores indicate greater patient satisfaction. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks postoperatively |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HPTC Wrap + Standard Extensor Tendon Repair | 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. High-Purity Type I Collagen (HPTC) Wrap: 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. Standard Extensor Tendon Repair: Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Standard Extensor Tendon Repair Alone | Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. Standard Extensor Tendon Repair: Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. | 0 | 30 | 0 | 30 | 1 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical site infection | Surgical and medical procedures | Non-systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Naveen Narayan | Adichunchanagiri Institute of Medical Sciences | +91-9980023372 | naveen_uno1@yahoo.co.in |
| Mar 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| >=65 years |
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| Male |
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| Zone VII |
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| Zone VIII |
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| Multiple tendon injuries |
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