Clinical trial NCT05600166: Double-layer Artificial Dermal Repair Material Combined With Growth Factors is Used for Exposed Tendon Wounds
Official title: A Prospective Cohort Study Evaluating the Efficacy of a Double-layer Artificial Dermal Repair Material Combined With Growth Factors for Exposed Tendon Wounds
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Open Wound of Hip With Tendon Involvement
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who met the inclusion criteria were selected for treatment at 6 hospitals

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.

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.

Primary outcomes:
measure: Wound closure evaluation
timeFrame: Two successive observations confirm the time when the wound is completely closed
measure: Wound closure evaluation
timeFrame: 7 days after the patient implanted the autologous blade thick skin tablet
measure: Functional evaluation
timeFrame: 3 months after surgery
measure: Functional evaluation
timeFrame: 6 months after surgery
measure: Functional evaluation
timeFrame: 3 months after surgery
measure: Functional evaluation
timeFrame: 6 months after surgery
measure: Appearance evaluation
timeFrame: 3 months after surgery
measure: Appearance evaluation
timeFrame: 6 months after surgery
measure: Appearance evaluation
timeFrame: 3 months after surgery
measure: Appearance evaluation
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
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Study officials:
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