Open Wound of Hip With Tendon InvolvementNCT05600166
Double-layer Artificial Dermal Repair Material Combined With Growth Factors is Used for Exposed Tendon Wounds
An observational study of Open Wound of Hip With Tendon Involvement, run by Wang xingang.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Wound of Hip With Tendon Involvement
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who met the inclusion criteria were selected for treatment at 6 hospitals
Who may be able to join
- 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;
- Incomplete aponeurosis;
- 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.
Who cannot join
- Wound infection or suspected osteomyelitis;
- Chronic wounds;
- More than 2/3 of the exposed tendons are suspended on the wound surface;
- Those with serious primary diseases such as cardiovascular and cerebrovascular, liver and kidney and hematopoietic system, which cannot be treated by surgery;
- Those who are allergic to collagen and chondroitin sulfate;
- Other persons that the investigator deems unsuitable.
About this study
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
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Wound closure evaluation
After transplantation of the autologous epidermis, it takes for the exposed tendon wound to heal 100%.
Measured: 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.
Measured: 7 days after the patient implanted the autologous blade thick skin tablet
Functional evaluation
Quick DASH
Measured: 3 months after surgery
Functional evaluation
Quick DASH
Measured: 6 months after surgery
Functional evaluation
Range of motion
Measured: 3 months after surgery
Functional evaluation
Range of motion
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Wound of Hip With Tendon InvolvementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang xingang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang xingang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600166
- Sponsor's protocol ID
- wxg1018
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05600166
- Acronym / sponsor ID
- wxg1018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Wang xingangUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who met the inclusion criteria were selected for treatment at 6 hospitals
Key inclusion criteria (3 listed)
- 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;
- Incomplete aponeurosis;
- 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.
Key exclusion criteria (6 listed)
- Wound infection or suspected osteomyelitis;
- Chronic wounds;
- More than 2/3 of the exposed tendons are suspended on the wound surface;
- Those with serious primary diseases such as cardiovascular and cerebrovascular, liver and kidney and hematopoietic system, which cannot be treated by surgery;
- Those who are allergic to collagen and chondroitin sulfate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound closure evaluation
Time frame: Two successive observations confirm the time when the wound is completely closed
After transplantation of the autologous epidermis, it takes for the exposed tendon wound to heal 100%.
Wound closure evaluation
Time frame: 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
Time frame: 3 months after surgery
Quick DASH
Functional evaluation
Time frame: 6 months after surgery
Quick DASH
Functional evaluation
Time frame: 3 months after surgery
Range of motion
Functional evaluation
Time frame: 6 months after surgery
Range of motion
Appearance evaluation
Time frame: 3 months after surgery
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.
Appearance evaluation
Time frame: 6 months after surgery
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.
Appearance evaluation
Time frame: 3 months after surgery
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.
Appearance evaluation
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Wound of Hip With Tendon Involvement, run by Wang xingang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure evaluation (time frame: Two successive observations confirm the time when the wound is completely closed). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.