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abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release (SENSE)

Primary Purpose

Carpal Tunnel Syndrome, Wound Infection, Suture, Complication

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Carpal Tunnel Release

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, wound infection, absorbable sutures, non-absorbable sutures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• indication for carpal tunnel release

Exclusion Criteria:

carpal tunnel syndrome which has yet been operated
injection with corticosteroids

Sites / Locations

Gelre ZiekenhuizenRecruiting
Deventer ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Absorbable sutures

Non-absorbable sutures

Arm Description

Absorbable sutures Vicryl rapide or Safil quick

Non-absorbable sutures Ethilon or Flexocrin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05431101

First Posted

June 21, 2022

Last Updated

September 13, 2023

Sponsor

Gelre Hospitals

Collaborators

Deventer Ziekenhuis

1. Study Identification

Unique Protocol Identification Number

NCT05431101

Brief Title

abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release

Acronym

SENSE

Official Title

Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

March 1, 2027 (Anticipated)

Study Completion Date

April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gelre Hospitals

Collaborators

Deventer Ziekenhuis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome, Wound Infection, Suture, Complication

Keywords

carpal tunnel syndrome, wound infection, absorbable sutures, non-absorbable sutures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2604 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Absorbable sutures

Arm Type

Active Comparator

Arm Description

Absorbable sutures Vicryl rapide or Safil quick

Arm Title

Non-absorbable sutures

Arm Type

Active Comparator

Arm Description

Non-absorbable sutures Ethilon or Flexocrin

Intervention Type

Procedure

Intervention Name(s)

Carpal Tunnel Release

Intervention Description

Transection of flexor retinaculum for patients who have carpal tunnel syndrome

Primary Outcome Measure Information:

Title

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)

Description

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

Time Frame

10 to 14 days post surgery

Secondary Outcome Measure Information:

Title

NRS score (Numeric Rating Scale for pain)

Description

pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0.

Time Frame

until three weeks post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • indication for carpal tunnel release Exclusion Criteria: carpal tunnel syndrome which has yet been operated injection with corticosteroids

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pauline Verhaegen, MD PHD

Phone

0555811244

paulineverhaegen@hotmail.com

Facility Information:

Facility Name

Gelre Ziekenhuizen

City

Apeldoorn

ZIP/Postal Code

7334DZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pauline Verhaegen

Phone

0555811244

p.verhaegen@gelre.nl

Facility Name

Deventer Ziekenhuis

City

Deventer

ZIP/Postal Code

7416SE

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edwin Wijburg

Phone

0555811244

e.wijburg@dz.nl

12. IPD Sharing Statement

Learn more about this trial

abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release

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