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Prospective Randomized Trial of Monocryl Versus Nylon Suture Closure in Carpal Tunnel Surgery

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ClinicalTrials.gov Identifier: NCT03950401
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The investigators will compare the early postoperative outcome of wound closure technique in carpal tunnel release using Nylon sutures versus subcuticular Monocryl sutures. The investigators plan to randomize patients across three hand surgeons who will perform both techniques, and will survey the patients satisfaction of pain and appearance at 2 and 6 weeks postoperatively.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Monocryl Procedure: Nylon Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to Monocryl versus subcuticular Nylon type of skin closure.
Masking: Single (Outcomes Assessor)
Masking Description: There is no way to mask the two techniques from the provider or patient since they will see the final result of the technique. The data analysis can be performed in a blinded manner.
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Monocryl Versus Nylon Suture Closure in Carpal Tunnel Surgery
Estimated Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 13, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: Monocryl
Closure of the skin at the completion of surgery by interrupted subcuticular technique with absorbable Monocryl suture.
Procedure: Monocryl
subcuticular Monocryl wound closure

Active Comparator: Nylon
Closure of the skin at the completion of surgery by interrupted technique on top of the skin with non-absorbable Nylon suture. These will be removed at the first postoperative visit.
Procedure: Nylon
wound closure using nylon suture on the skin




Primary Outcome Measures :
  1. Patient and Observer Scar Assessment Scale (POSAS) Score - Patient [ Time Frame: 6 weeks ]
    As measured by a questionnaire completed by the patient. The patient scale consists of 6 items scored on a scale ranging from 1 ('no, not at all' or 'no, normal skin') to 10 ('yes, very much' or 'yes, very different'). Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.

  2. Patient and Observer Scar Assessment Scale (POSAS) Score - Observer [ Time Frame: 6 weeks ]
    As measured by a questionnaire completed by the clinic physician assistant. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 6 weeks ]
    Patients will be asked the following question: "How satisfied are you with the results of the carpal tunnel surgery and recovery?" Assessed using a 5-point scale: completely satisfied (1 point), very satisfied (2 point), rather satisfied (3 point), dissatisfied (4 point), and completely dissatisfied (5 point).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at the University of California, Davis Health Center who are scheduled to undergo surgery for carpal tunnel release will be screened for eligibility for this study.
  • Patients who do not speak English will be included in this study, and will be provided with appropriate translators at all communication points.

Exclusion Criteria:

  • Patients who are not able to follow up at the 2 and 6 week postoperative time points.
  • Patients who have known skin sensitivity to tape or absorbable suture.
  • Those who are unable to give informed consent, individuals who are not yet adults (18 years or older), pregnant women, and prisoners will be excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950401


Contacts
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Contact: Laura A Sonoda, MD, MPH 9157342807 lasonoda@ucdavis.edu
Contact: Robert M Szabo, MD, MPH 9157342807 rmszabo@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Laura A Sonoda, MD, MPH    916-734-2807    lasonoda@ucdavis.edu   
Contact: Robert Szabo, MD, MPH    9167342807    rmszabo@ucdavis.edu   
Sub-Investigator: Katharine Hinchcliff, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Robert M Szabo, MD, MPH University of California, Davis

Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03950401     History of Changes
Other Study ID Numbers: 1386423
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Correspondence of participants, their status in the study and the survey questions will be through encrypted excel document within encrypted OneDrive sharing folder with a link that is personally sent to the participants of the study.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Upon first patient enrollment, until completion of data analysis, likely at 2 years.
Access Criteria: Completed HIPAA and human subjects research training as enforced by University of California, Davis, and included as a participant of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of California, Davis:
skin closure

Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries