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

Not yet recruiting

• Conditions: Open Wound of Hip With Tendon Involvement

• Registration Number: NCT05600166
• Lead Sponsor: Wang xingang

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Study Start: 2022-11-01
• Primary Completion: 2023-04-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound closure evaluation	7 days after the patient implanted the autologous blade thick skin tablet	One week after transplantation of the autologous epidermis, the survival rate of skin grafting on the exposed tendon wound is localized.
Functional evaluation	6 months after surgery	Range of motion
Appearance evaluation	6 months after surgery	VSS（Vancouver scar scale） score of the supply 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.