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

NCT ID: NCT05600166

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-10-31

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.

Conditions

Open Wound of Hip With Tendon Involvement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Wang xingang

OTHER

Sponsor Role: lead

Responsible Party

Wang xingang

Deputy Director

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

wxg1018

Identifier Type: -

Identifier Source: org_study_id