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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Open Wound of Hip With Tendon Involvement

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 Type: Observational
• Enrollment (Anticipated): 110

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who met the inclusion criteria were selected for treatment at 6 hospitals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental group; Participants were treated with artificial dermal repair materials in combination with growth factors.
Control group; Cases treated with a double layer of artificial dermal repair material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound closure evaluation	After transplantation of the autologous epidermis, it takes for the exposed tendon wound to heal 100%.	Two successive observations confirm the time when the wound is completely closed
Wound closure evaluation	One week after transplantation of the autologous epidermis, the survival rate of skin grafting on the exposed tendon wound is localized.	7 days after the patient implanted the autologous blade thick skin tablet
Functional evaluation	Quick DASH	3 months after surgery
Functional evaluation	Quick DASH	6 months after surgery
Functional evaluation	Range of motion	3 months after surgery
Functional evaluation	Range of motion	6 months after surgery
Appearance evaluation	VSS（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.	3 months after surgery
Appearance evaluation	VSS（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.	6 months after surgery
Appearance evaluation	VSS（Vancouver scar scale） score of the 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.	3 months after surgery
Appearance evaluation	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.	6 months after surgery

Collaborators and Investigators

• Sponsor: Wang xingang

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: wxg1018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No