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Biological Amnion Prevents Flexor Tendon Adhesion in Zone II: A Controlled, Multicentre Clinical Trial

Biological Amnion Prevents Flexor Tendon Adhesion in Zone II: A Controlled, Multicentre Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021769
Enrollment
Unknown
Registered
2019-03-08
Start date
2015-07-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The adhesion of flexor tendon

Interventions

Control group:Tendon suture
PDLLA group:Tendon suture plus PDLLA wrapping
Amnion group:Tendon suture plus amniotic membrane wrapping

Sponsors

The Third Affiliated Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Complete rupture of the flexor tendon in zone II; 2. Aged 21 to 65 years, male or female; 3. The time from injury to operation was less than 6 h; 4. The soft tissue allowed direct skin closure; 5. Only one hand was injured; 6. Written informed consent to undergo the surgical procedure.

Exclusion criteria

Exclusion criteria: 1. Thumb injuries; 2. Patients with vascular injuries requiring revascularisation; 3. Concomitant phalanx fractures or other injuries needing immobilisation; 4. The tendon was secondary ruptured; 5. Loss of skin substance requiring grafts or flaps; 6. Uncompensated diabetes, autoimmune collagenopathies, neoplasia haemocoagulative alterations or psychic disorders and smokers.

Design outcomes

Primary

MeasureTime frame
Range of active digital motion;

Secondary

MeasureTime frame
The functional recovery of flexor tendons;

Countries

China

Contacts

Public ContactTian Dehu

Department of Hand Surgery,The Third Affiliated Hospital of Hebei Medical University

tiandehu_1961@126.com+86 18533112810

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026