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Status unknownNCT05600166Updated Oct 31, 2022

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

An observational study in Open Wound of Hip With Tendon Involvement, sponsored by Wang xingang. Status unknown. Per ClinicalTrials.gov, last updated 2022-10-31.

Sponsored by Wang xingang · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Sex
All
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Study 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.

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.

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Conditions studied

  • Open Wound of Hip With Tendon Involvement

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 110 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

This is the only study on the registry with Wang xingang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Wound closure evaluation

    After transplantation of the autologous epidermis, it takes for the exposed tendon wound to heal 100%.

    Time frame: Two successive observations confirm the time when the wound is completely closed

  2. Wound closure evaluation

    One week after transplantation of the autologous epidermis, the survival rate of skin grafting on the exposed tendon wound is localized.

    Time frame: 7 days after the patient implanted the autologous blade thick skin tablet

  3. Functional evaluation

    Quick DASH

    Time frame: 3 months after surgery

  4. Functional evaluation

    Quick DASH

    Time frame: 6 months after surgery

  5. Functional evaluation

    Range of motion

    Time frame: 3 months after surgery

  6. Functional evaluation

    Range of motion

    Time frame: 6 months after surgery

  7. 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.

    Time frame: 3 months after surgery

  8. 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.

    Time frame: 6 months after surgery

  9. 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.

    Time frame: 3 months after surgery

  10. 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.

    Time frame: 6 months after surgery

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05600166
Lead sponsor
Wang xingang
Responsible party
Wang xingang (Deputy Director, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Sponsor-investigator
First posted
Oct 31, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Apr 30, 2023 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Oct 31, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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