Carpal Tunnel SyndromeSENSENCT05431101
abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release
A study testing Carpal Tunnel Release in people with Carpal Tunnel Syndrome and Wound Infection, run by Gelre Hospitals at 2 sites in Netherlands.
Trial summary
Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Wound Infection, Suture, Complication
- What is being tested?
- Carpal Tunnel Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,604 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 May 2022to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for carpal tunnel release
Who cannot join
- carpal tunnel syndrome which has yet been operated
- injection with corticosteroids
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Gelre Ziekenhuizen
Apeldoorn, 7334DZ
Pauline Verhaegen, 0555811244, p.verhaegen@gelre.nl
- Recruiting
Deventer Ziekenhuis
Deventer, 7416SE
Edwin Wijburg, 0555811244, e.wijburg@dz.nl
About this study
Official title: Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial
Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.
Read the detailed description
Carpal Tunnel Syndrome is a prevalent condition; up to 9% in women and 0.6% in men. It causes complaints of paresthesia, pain, numbness and loss of strength. Surgical decompression is the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of suture material which is used can influence the prevalence of wound infection. In current clinical practice both absorbable and non absorbable sutures are used. In literature, various hypothesis are described: Absorbable sutures could give more reaction of macrophages and therefore a higher chance on infection. This would not be the case for non-absorbable sutures, since they will be removed. However, in literature, there is still not enough evidence for superiority of absorbable or non-absorbable suture. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.
The primary outcome is the ASEPSIS wound score. This will be scored by independent investigators.
Use of antibiotics, handtherapy and extra outpatient visits will be recorded.
Patients are asked to register their NRS scores the first three weeks after surgery.
- Being tested
- Carpal Tunnel Release
- Keywords
- carpal tunnel syndrome, wound infection, absorbable sutures, non-absorbable sutures
- Medical subject headings
- Carpal Tunnel Syndrome, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal Tunnel ReleaseProcedure or surgery
Transection of flexor retinaculum for patients who have carpal tunnel syndrome
| Study group | Role | What they receive |
|---|---|---|
| Absorbable sutures | Active comparator | Absorbable sutures Vicryl rapide or Safil quick Receives: Procedure: Carpal Tunnel Release |
| Non-absorbable sutures | Active comparator | Non-absorbable sutures Ethilon or Flexocrin Receives: Procedure: Carpal Tunnel Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASEPSIS wound score (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days)
score based on a picture made of the wound 10-14 days post carpal tunnel release. Minimum score 0, maximum score 70, score above 40 is categorized as wound infection
Measured: 10 to 14 days post surgery
Secondary outcomes (1)
NRS score (Numeric Rating Scale for pain)
pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0.
Measured: until three weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 May 2022
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- None (open label)
- Enrolment
- 2,604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelre Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Deventer Ziekenhuis
- Responsible party
- Principal investigator, Pauline Verhaegen, Gelre Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431101
- Sponsor's protocol ID
- 21/551
- Acronym
- SENSE
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2022
- Last updated
- 26 Aug 2025
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05431101
- Acronym / sponsor ID
- SENSE / 21/551
- Keywords
- carpal tunnel syndrome, wound infection, absorbable sutures, non-absorbable sutures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,604 participants (estimated)
- Lead sponsor
- Gelre HospitalsUniversity, hospital or other
- Collaborators
- Deventer Ziekenhuis
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 24 Jun 2022 (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.
Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.
Detailed description
Carpal Tunnel Syndrome is a prevalent condition; up to 9% in women and 0.6% in men. It causes complaints of paresthesia, pain, numbness and loss of strength. Surgical decompression is the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of suture material which is used can influence the prevalence of wound infection. In current clinical practice both absorbable and non absorbable sutures are used. In literature, various hypothesis are described: Absorbable sutures could give more reaction of macrophages and therefore a higher chance on infection. This would not be the case for non-absorbable sutures, since they will be removed. However, in literature, there is still not enough evidence for superiority of absorbable or non-absorbable suture. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.
The primary outcome is the ASEPSIS wound score. This will be scored by independent investigators.
Use of antibiotics, handtherapy and extra outpatient visits will be recorded.
Patients are asked to register their NRS scores the first three weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable sutures | Active comparator | Procedure: Carpal Tunnel ReleaseAbsorbable sutures Vicryl rapide or Safil quick |
| Non-absorbable sutures | Active comparator | Procedure: Carpal Tunnel ReleaseNon-absorbable sutures Ethilon or Flexocrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for carpal tunnel release
Key exclusion criteria (2 listed)
- carpal tunnel syndrome which has yet been operated
- injection with corticosteroids
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 |
|---|---|---|
| Carpal Tunnel ReleaseTransection of flexor retinaculum for patients who have carpal tunnel syndrome | Procedure or surgery | Absorbable sutures, Non-absorbable sutures |
Primary outcome
ASEPSIS wound score (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days)
Time frame: 10 to 14 days post surgery
score based on a picture made of the wound 10-14 days post carpal tunnel release. Minimum score 0, maximum score 70, score above 40 is categorized as wound infection
1 secondary outcome
NRS score (Numeric Rating Scale for pain)
Time frame: until three weeks post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Related trials for Carpal Tunnel Syndrome
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Not yet recruitingObservational study
Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS)
Not yet recruiting
Effectiveness of Sensorimotor Proprioceptive Stimulation Combined With Conventional Physical Therapy on Symptoms, Sensory Function, Proprioception, and Hand Function in Patients With Mild-to-Moderate Carpal Tunnel Syndrome
Carpel Tunnel Syndrome
Recruiting
Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome
Carpal Tunnel Syndrome
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal Tunnel Release in people with Carpal Tunnel Syndrome and Wound Infection, run by Gelre Hospitals at 2 sites in Netherlands.
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 2 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: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Verhaegen, MD PHD (0555811244, paulineverhaegen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASEPSIS wound score (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days) (time frame: 10 to 14 days post 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 26 Aug 2025.