All Minor Hand Surgery IncludingNCT03407820
Nylon Versus Chromic Gut Sutures for Minor Hand Surgery
A study testing Absorbable Chromic gut sutures and Non-absorbable Nylon sutures in people with All Minor Hand Surgery Including and Carpal Tunnel Syndrome, run by University of Texas at Austin at 3 sites in United States.
Trial summary
This study aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- All Minor Hand Surgery Including, Carpal Tunnel Syndrome, Trigger Finger
- What is being tested?
- Absorbable Chromic gut sutures and Non-absorbable Nylon sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jan 2018to 1 Aug 2022
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing common day-case elective hand surgery under local anesthesia, one of the following (initial) procedures:
- Carpal tunnel release
- Trigger finger release
- Ganglion excision
- Excisional biopsy
- De Quervain release
Show all 14Show fewer
- Dupuytren fasciectomy
- Any other minor hand surgery
- Patients aged 18-89
- Able to provide informed consent
- Able to understand English or Spanish to complete questionnaires
- Patients who have an email-address or phone number (needed for follow-up)
- UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Orthopaedic Specialists of Austin.
- Available for follow-up contact after 4 weeks
Who cannot join
- Patients not able to give informed consent
- Patients using corticosteroids
- Patients with one of the following comorbidities: bleeding disorder, immunodeficiency, collagen vascular disease.
- Patients known to be allergic to suture materials
- Revision procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Austin Regional Clinic
Austin, Texas, 78705
HTB Musculoskeletal Institute
Austin, Texas, 78712
Orthopedic Specialists of Austin
Austin, Texas, 78751
About this study
Official title: Randomized Controlled Trial Comparing Nylon and Chromic Gut Sutures After Minor Hand Surgery
This study aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors associated with wound concerns, pain intensity, magnitude of limitations, and physical function within one month of surgery.
- Conditions
- All Minor Hand Surgery Including, Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts, De Quervain Syndrome, Dupuytren Contracture
- Being tested
- Absorbable Chromic gut sutures, Non-absorbable Nylon sutures
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder, Ganglion Cysts, Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Chromic gut suturesProcedure or surgery
In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received absorbable Chromic sutures are treated recording to the standard protocol and they are advised that they can start to gently rub the scab and suture line to encourage the sutures to fall off starting 10-14 days postoperatively.
Non-absorbable Nylon suturesProcedure or surgery
In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received Nylon sutures are treated recording to the standard protocol and sutures are removed after the usual time (10-14 days) of the received procedure.
| Study group | Role | What they receive |
|---|---|---|
| 1st random 50% of cohort | Active comparator | Absorbable Chromic gut sutures Receives: Procedure: Absorbable Chromic gut sutures |
| 2nd random 50% of cohort | Active comparator | Non-absorbable Nylon sutures Receives: Procedure: Non-absorbable Nylon sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction measured on an 11-point ordinal scale
The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Measured: Four weeks after surgery
Secondary outcomes (5)
Factors associated with wound concerns within one month of surgery
Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. Wound concerns will be assessed by number of contacts with questions for wound concerns.
Measured: Four weeks after surgery
Factors associated with pain intensity (11 point ordinal scale) within one month of surgery
Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher pain intensity.
Measured: Four weeks after surgery
Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery
Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. PROMIS-UE PF scores are reported as T-scores with a mean of 50 and SD of 10, with higher scores representing higher levels of physical function.
Measured: Four weeks after surgery
Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery
Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher scar satisfaction.
Measured: Four weeks after surgery
Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale
he scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Measured: Four weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start31 Jan 2018
- Primary completion30 May 2020
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Minor Hand Surgery IncludingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407820
- Sponsor's protocol ID
- 2017-11-0021
- Status last verified
- Jul 2025
- First submitted
- 8 Jan 2018
- Last updated
- 31 Jul 2025
- Results posted
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Nylon and Chromic Gut Sutures After Minor Hand Surgery
- ClinicalTrials.gov ID
- NCT03407820
- Acronym / sponsor ID
- 2017-11-0021
- Conditions
- All Minor Hand Surgery Including, Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts, De Quervain Syndrome, Dupuytren Contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 23 Jan 2018 (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 aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors associated with wound concerns, pain intensity, magnitude of limitations, and physical function within one month of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st random 50% of cohort | Active comparator | Procedure: Absorbable Chromic gut suturesAbsorbable Chromic gut sutures |
| 2nd random 50% of cohort | Active comparator | Procedure: Non-absorbable Nylon suturesNon-absorbable Nylon sutures |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All patients undergoing common day-case elective hand surgery under local anesthesia, one of the following (initial) procedures:
- Patients aged 18-89
- Able to provide informed consent
- Able to understand English or Spanish to complete questionnaires
- Patients who have an email-address or phone number (needed for follow-up)
Key exclusion criteria (5 listed)
- Patients not able to give informed consent
- Patients using corticosteroids
- Patients with one of the following comorbidities: bleeding disorder, immunodeficiency, collagen vascular disease.
- Patients known to be allergic to suture materials
- Revision procedures
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 |
|---|---|---|
| Absorbable Chromic gut suturesIn this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received absorbable Chromic sutures are treated recording to the standard protocol and they are advised that they can start to gently rub the scab and suture line to encourage the sutures to fall off starting 10-14 days postoperatively. | Procedure or surgery | 1st random 50% of cohort |
| Non-absorbable Nylon suturesIn this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received Nylon sutures are treated recording to the standard protocol and sutures are removed after the usual time (10-14 days) of the received procedure. | Procedure or surgery | 2nd random 50% of cohort |
Primary outcome
Treatment satisfaction measured on an 11-point ordinal scale
Time frame: Four weeks after surgery
The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
5 secondary outcomes
Factors associated with wound concerns within one month of surgery
Time frame: Four weeks after surgery
Factors associated with pain intensity (11 point ordinal scale) within one month of surgery
Time frame: Four weeks after surgery
Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery
Time frame: Four weeks after surgery
Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery
Time frame: Four weeks after surgery
Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale
Time frame: Four weeks after surgery
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 31 Jul 2025.
- Individual participant dataSharing planned: No
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.
David Ring, MD PhD principal investigator
University of Texas at Austin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable Chromic gut sutures and Non-absorbable Nylon sutures in people with All Minor Hand Surgery Including and Carpal Tunnel Syndrome, run by University of Texas at Austin at 3 sites 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 14 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Treatment satisfaction measured on an 11-point ordinal scale (time frame: Four weeks after surgery). 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 Jul 2025.