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Double-layer Artificial Dermal Repair Material Combined With Growth Factors is Used for Exposed Tendon Wounds

A Prospective Cohort Study Evaluating the Efficacy of a Double-layer Artificial Dermal Repair Material Combined With Growth Factors for Exposed Tendon Wounds

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05600166
Enrollment
110
Registered
2022-10-31
Start date
2022-11-01
Completion date
2024-10-31
Last updated
2022-10-31

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

Conditions

Open Wound of Hip With Tendon Involvement

Brief summary

Compared with the combination of double-layer artificial dermal repair materials combined with growth factors, and the treatment methods using double-layer artificial dermal repair materials, the time and effect of the two treatment regimens on the function and appearance of wound repair with exposed tendon were different, as well as the medical costs.

Detailed description

This study used a prospective cohort study to select all patients who met the inclusion criteria in six hospitals within six months after the start of the trial, including no less than 55 patients receiving artificial dermis combined with growth factor and no less than 110 patients receiving simple artificial dermal treatment, and the cumulative number of patients was not less than 110 patients, to compare the time and effect of the two treatment options on the functional and cosmetic restoration of upper limb wound repair with exposed tendons.

Interventions

None listed

Sponsors

Wang xingang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Elbow joint to fingertip area, soft tissue defect accompanied by tendon exposed fresh wound, tendon exposed wound area of 2\ 20cm2, wound area 5-600cm2, need to transplant autologous skin; 2. Incomplete aponeurosis; 3. Voluntarily sign the informed consent form. For persons with no or limited capacity for civil conduct, obtain the consent of their guardians and sign an informed consent form.

Exclusion criteria

1. Wound infection or suspected osteomyelitis; 2. Chronic wounds; 3. More than 2/3 of the exposed tendons are suspended on the wound surface; 4. Those with serious primary diseases such as cardiovascular and cerebrovascular, liver and kidney and hematopoietic system, which cannot be treated by surgery; 5. Those who are allergic to collagen and chondroitin sulfate; 6. Other persons that the investigator deems unsuitable.

Design outcomes

Primary

MeasureTime frameDescription
Wound closure evaluationTwo successive observations confirm the time when the wound is completely closedAfter transplantation of the autologous epidermis, it takes for the exposed tendon wound to heal 100%.
Functional evaluation3 months after surgeryQuick DASH
Appearance evaluation3 months after surgeryVSS(Vancouver scar scale) score of the receiving area .About scars, color 0\ 3 points; Thickness 0\ 4 minutes; Vascular distribution 0\ 3 points; Softness: 0\ 5 points. All the points are added together, the smaller the better.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026