Hand SurgeryNCT04656834
Hand Incision Study
An observational study of Hand Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Surgery
- What is being tested?
- hand incision closure using monocryl sutures and skin glue and hand incision closure using simple nylon sutures
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 30 Nov 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Participants who are 18 years old or older who are having surgery for either a trigger finger release or carpal tunnel release by one of Rothman Orthopaedics Hand \& Wrist Surgeons
Who may be able to join
- Patients ≥ 18 years old
- Able to provide consent
- Undergoing either trigger finger release or carpal tunnel release
Who cannot join
- Patients < 18 years old
- Unable to provide consent
- Unable to comply with follow up requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Hand Surgical Incision Outcomes
The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.
- Conditions
- Hand Surgery
- Being tested
- hand incision closure using monocryl sutures and skin glue, hand incision closure using simple nylon sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand incision closure using monocryl sutures and skin glueProcedure or surgery
At the end of surgery, the investigator will close the incision using monocryl sutures and skin glue
hand incision closure using simple nylon suturesProcedure or surgery
At the end of surgery, the investigator will close the incision using simple nylon sutures
| Study group | Role | What they receive |
|---|---|---|
| Hand incision closure type 1 | The participating surgeon closes the hand surgical incision via the standard method based on personal preference: buried monocryl sutures and skin glue Receives: Procedure: hand incision closure using monocryl sutures and skin glue | |
| Hand incision closure type 2 | The participating surgeon closes the hand surgical incision via the standard method based on personal preference: simple nylon sutures Receives: Procedure: hand incision closure using simple nylon sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction with Scar Appearance (Questionnaire #1)
Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Patient Scar Assessment Questionnaire (PSAQ).
Measured: 12 weeks
Participant Satisfaction with Scar Appearance (Questionnaire #2)
Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Stony Brook Scar Evaluation Scale (SBSES)
Measured: 12 weeks
Participant Satisfaction with Scar Appearance (Questionnaire #3)
Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Visual Analog Scale (VAS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656834
- Sponsor's protocol ID
- AILY20D.947
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 7 Dec 2020
- 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 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Surgical Incision Outcomes
- ClinicalTrials.gov ID
- NCT04656834
- Acronym / sponsor ID
- AILY20D.947
- Conditions
- Hand Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 7 Dec 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.
The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand incision closure type 1 | – | Procedure: hand incision closure using monocryl sutures and skin glueThe participating surgeon closes the hand surgical incision via the standard method based on personal preference: buried monocryl sutures and skin glue |
| Hand incision closure type 2 | – | Procedure: hand incision closure using simple nylon suturesThe participating surgeon closes the hand surgical incision via the standard method based on personal preference: simple nylon sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants who are 18 years old or older who are having surgery for either a trigger finger release or carpal tunnel release by one of Rothman Orthopaedics Hand \& Wrist Surgeons
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old
- Able to provide consent
- Undergoing either trigger finger release or carpal tunnel release
Key exclusion criteria (3 listed)
- Patients < 18 years old
- Unable to provide consent
- Unable to comply with follow up requirements
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 |
|---|---|---|
| hand incision closure using monocryl sutures and skin glueAt the end of surgery, the investigator will close the incision using monocryl sutures and skin glue | Procedure or surgery | Hand incision closure type 1 |
| hand incision closure using simple nylon suturesAt the end of surgery, the investigator will close the incision using simple nylon sutures | Procedure or surgery | Hand incision closure type 2 |
Primary outcome
Participant Satisfaction with Scar Appearance (Questionnaire #1)
Time frame: 12 weeks
Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Patient Scar Assessment Questionnaire (PSAQ).
Participant Satisfaction with Scar Appearance (Questionnaire #2)
Time frame: 12 weeks
Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Stony Brook Scar Evaluation Scale (SBSES)
Participant Satisfaction with Scar Appearance (Questionnaire #3)
Time frame: 12 weeks
Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Visual Analog Scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
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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 Hand Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
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 3 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 7 Dec 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 United States. 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?
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?
Participant Satisfaction with Scar Appearance (Questionnaire #1) (time frame: 12 weeks). The study lists 3 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 7 Dec 2020.