Wound HealingNCT04455490
Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture
An observational study of Wound Healing, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases treated with this treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Healing
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2020to 18 May 2020
- 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: 4 patients with delayed healing after Achilles tendon suture surgery who were treated at our institution, in the period from April 2008 to July 2019. The patients were 3 men and 1 woman, aged 39 to 60 years. Among them, 3 had surgery on the left Achilles tendon and 1 had surgery on the right Achilles tendon. The time from the first operation (Achilles tendon suture) to foreign body reaction ranged from 1 month to 5 months.
Who may be able to join
- The diagnostic criteria for delayed wound healing after Achilles tendon suture are met, namely the presence of skin necrosis, wound nonunion, or delayed wound healing.
Who cannot join
- The expected healing time of wounds with regular dressing changes is <2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases treated with this treatment. The analysis results of the clinical efficacy of the method can serve as a reference for clinical and surgical decision-making and prognosis assessment.
Read the detailed description
Background: Delayed wound healing is a kind of postoperative complication of Achilles tendon suture. Conventional surgical approach is open surgery in order to clean the wound, which requires multiple dressing changes and involves a longer recovery period. We recently developed arthroscopic surgery for delayed wound healing after Achilles tendon suture. This therapy may be an alternative approach to open surgery.
Purposes: In this paper we evaluate the long-term efficacy of endoscopic surgery for delayed wound healing after Achilles tendon suture.
Patients and Methods: Clinical data of 4 patients with delayed wound healing after Achilles tendon suture who underwent endoscopic surgery from April 2008 to October 2017 at our institute were retrospectively analyzed. There were 3 males and 1 females with age of 39-60 years, the follow-up period was 8-43 months). All the patients had unilateral tendon rupture with 3 cases on the left and 1 cases on the right. Scores on Visual analogue scale(VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were used. The postoperative outcome was evaluated on the basis of Victorian Institute of Sport Assessment-Achilles score and Achilles tendon total rupture score (ATRS).
- Conditions
- Wound Healing
- Being tested
- Self-control
- Keywords
- Achilles tendon suture, Delayed wound healing, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-controlOther
We compared relevant scores of patients before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Delayed wound healing | Patients with delayed wound healing after Achilles tendon suture who were treated at Peking University Third Hospital Receives: Other: Self-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received endoscopic surgery. VAS ranges from 0 to 10, higher scores mean a worse outcome.
Measured: 8 months to 4 years after the surgery
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Use American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score(AOFAS) to evaluate the function recovery of patients who received endoscopic surgery. AOFAS ranges from 0 to 100, higher scores mean a better outcome.
Measured: 8 months to 4 years after the surgery
Victorian Institute of Sport Assessment-Achilles
Use Victorian Institute of Sport Assessment-Achilles(VISA-A) to evaluate the pain and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.
Measured: 8 months to 4 years after the surgery
Achilles tendon total rupture score
Use Achilles tendon total rupture score(ATRS) to evaluate the function and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.
Measured: 8 months to 4 years after the surgery
Tegner knee motion score
Use Tegner knee motion score to evaluate the sports ability of patients who received endoscopic surgery. Tegner knee motion score ranges from 0 to 10, higher scores mean a better outcome.
Measured: 8 months to 4 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start18 Mar 2020
- Primary completion18 Apr 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455490
- Sponsor's protocol ID
- M2019492
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture
- ClinicalTrials.gov ID
- NCT04455490
- Acronym / sponsor ID
- M2019492
- Conditions
- Wound Healing
- Keywords
- Achilles tendon suture, Delayed wound healing, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 2 Jul 2020 (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.
This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases treated with this treatment. The analysis results of the clinical efficacy of the method can serve as a reference for clinical and surgical decision-making and prognosis assessment.
Detailed description
Background: Delayed wound healing is a kind of postoperative complication of Achilles tendon suture. Conventional surgical approach is open surgery in order to clean the wound, which requires multiple dressing changes and involves a longer recovery period. We recently developed arthroscopic surgery for delayed wound healing after Achilles tendon suture. This therapy may be an alternative approach to open surgery.
Purposes: In this paper we evaluate the long-term efficacy of endoscopic surgery for delayed wound healing after Achilles tendon suture.
Patients and Methods: Clinical data of 4 patients with delayed wound healing after Achilles tendon suture who underwent endoscopic surgery from April 2008 to October 2017 at our institute were retrospectively analyzed. There were 3 males and 1 females with age of 39-60 years, the follow-up period was 8-43 months). All the patients had unilateral tendon rupture with 3 cases on the left and 1 cases on the right. Scores on Visual analogue scale(VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were used. The postoperative outcome was evaluated on the basis of Victorian Institute of Sport Assessment-Achilles score and Achilles tendon total rupture score (ATRS).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delayed wound healing | – | Other: Self-controlPatients with delayed wound healing after Achilles tendon suture who were treated at Peking University Third Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 4 patients with delayed healing after Achilles tendon suture surgery who were treated at our institution, in the period from April 2008 to July 2019. The patients were 3 men and 1 woman, aged 39 to 60 years. Among them, 3 had surgery on the left Achilles tendon and 1 had surgery on the right Achilles tendon. The time from the first operation (Achilles tendon suture) to foreign body reaction ranged from 1 month to 5 months.
Key inclusion criteria (1 listed)
- The diagnostic criteria for delayed wound healing after Achilles tendon suture are met, namely the presence of skin necrosis, wound nonunion, or delayed wound healing.
Key exclusion criteria (1 listed)
- The expected healing time of wounds with regular dressing changes is <2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-controlWe compared relevant scores of patients before and after surgery | Other | Delayed wound healing |
Primary outcome
Visual Analogue Scale
Time frame: 8 months to 4 years after the surgery
Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received endoscopic surgery. VAS ranges from 0 to 10, higher scores mean a worse outcome.
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time frame: 8 months to 4 years after the surgery
Use American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score(AOFAS) to evaluate the function recovery of patients who received endoscopic surgery. AOFAS ranges from 0 to 100, higher scores mean a better outcome.
Victorian Institute of Sport Assessment-Achilles
Time frame: 8 months to 4 years after the surgery
Use Victorian Institute of Sport Assessment-Achilles(VISA-A) to evaluate the pain and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.
Achilles tendon total rupture score
Time frame: 8 months to 4 years after the surgery
Use Achilles tendon total rupture score(ATRS) to evaluate the function and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.
Tegner knee motion score
Time frame: 8 months to 4 years after the surgery
Use Tegner knee motion score to evaluate the sports ability of patients who received endoscopic surgery. Tegner knee motion score ranges from 0 to 10, higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (time frame: 8 months to 4 years after the surgery). The study lists 5 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 2 Jul 2020.