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

NCT ID: NCT05600166

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Open Wound of Hip With Tendon Involvement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Participants were treated with artificial dermal repair materials in combination with growth factors.

No interventions assigned to this group

Control group

Cases treated with a double layer of artificial dermal repair material

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wang xingang

OTHER

Sponsor Role lead

Responsible Party

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Wang xingang

Deputy Director

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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wxg1018

Identifier Type: -

Identifier Source: org_study_id