ScarNCT03842644
Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring
A study testing Tension reduction device in people with Scar, run by XiaoXi Lin at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Scar
- What is being tested?
- Tension reduction device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2019to 25 Oct 2020
- Phase
- Interventional
- 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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The incision is not shorter than 3cm
- Skin type is III/IV
Who cannot join
- Any medical history of facial surgery, not included injection therapy, external medication or fat graft
- Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
- Patients with a history of keloid or family history of keloid
- Patients with serious skin disorders, eg. serious psoriasis or dermatitis
- Patients with severe systemic or congenital disease which may affect the patient's safety in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.
The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.
Read the detailed description
Primary measurement: the mean scar width calculated by standard photos with rulers.
Secondary measure: the probability of scar hyperplasia.
- Conditions
- Scar
- Being tested
- Tension reduction device
- Keywords
- Tension Reduction
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension reduction deviceDevice
Also called Zipline Surgical Skin Closure Device
Continue using this device for 3 months post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tension Reduction | Experimental | Tension reduction device for 3 months post surgery Receives: Device: Tension reduction device |
| Control | No intervention | No tension reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar width
scar width is measure by standard photo with ruler
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Hypertrophic scar rate
The onset of hypertrophic scar will be documented in the time of follow-up. The red and stiffness scar which higher than the surrounding skin surface will be considered as hypertrophic scar.
Measured: through study completion, an average of 1 year
Patient and observer scar assessment scale score
Subscale 1: observer scar assessment scale (score range 5-50), the score 50 is considered as the worse outcome.
Subscale 2: patient scar assessment scale (score range 5-50), the score 50 is considered as the worse outcome.
Measured: through study completion, an average of 1 year
Vancouver Scar Scale
total score range from 0 to 14, the score14 is considered as the worse outcome
Measured: through study completion, an average of 1 year
Relative side effect
The relative side effect will be documented in each time of follow-up.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start16 Feb 2019
- Primary completion25 Oct 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- XiaoXi Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoXi Lin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Lin, Professor, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842644
- Sponsor's protocol ID
- SH9H-2018-T65-2
- Status last verified
- Oct 2020
- First submitted
- 2 Feb 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03842644
- Acronym / sponsor ID
- SH9H-2018-T65-2
- Conditions
- Scar
- Keywords
- Tension Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- XiaoXi LinUniversity, hospital or other
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 15 Feb 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.
Detailed description
Primary measurement: the mean scar width calculated by standard photos with rulers.
Secondary measure: the probability of scar hyperplasia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension Reduction | Experimental | Device: Tension reduction deviceTension reduction device for 3 months post surgery |
| Control | No intervention | –No tension reduction |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The incision is not shorter than 3cm
- Skin type is III/IV
Key exclusion criteria (5 listed)
- Any medical history of facial surgery, not included injection therapy, external medication or fat graft
- Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
- Patients with a history of keloid or family history of keloid
- Patients with serious skin disorders, eg. serious psoriasis or dermatitis
- Patients with severe systemic or congenital disease which may affect the patient's safety in this study
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 |
|---|---|---|
| Tension reduction deviceAlso: Zipline Surgical Skin Closure DeviceContinue using this device for 3 months post surgery. | Device | Tension Reduction |
Primary outcome
Scar width
Time frame: through study completion, an average of 1 year
scar width is measure by standard photo with ruler
4 secondary outcomes
Hypertrophic scar rate
Time frame: through study completion, an average of 1 year
Patient and observer scar assessment scale score
Time frame: through study completion, an average of 1 year
Vancouver Scar Scale
Time frame: through study completion, an average of 1 year
Relative side effect
Time frame: through study completion, an average of 1 year
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 29 Oct 2020.
Related trials for Scar
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
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.
Lin, Professor principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension reduction device in people with Scar, run by XiaoXi Lin 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 2 inclusion and 5 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 29 Oct 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?
Scar width (time frame: through study completion, an average of 1 year). 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 29 Oct 2020.