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 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Procedure: Monocryl Procedure: Nylon||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||141 participants|
|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.|
|Official Title:||Prospective Randomized Trial of Monocryl Versus Nylon Suture Closure in Carpal Tunnel Surgery|
|Actual Study Start Date :||May 16, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: Monocryl
Closure of the skin at the completion of surgery by interrupted subcuticular technique with absorbable Monocryl suture.
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.
wound closure using nylon suture on the skin
- 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.
- 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.
- 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).
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
|Contact: Laura A Sonoda, MD, MPHemail@example.com|
|Contact: Robert M Szabo, MD, MPHfirstname.lastname@example.org|
|United States, California|
|University of California, Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Laura A Sonoda, MD, MPH 916-734-2807 email@example.com|
|Contact: Robert Szabo, MD, MPH 9167342807 firstname.lastname@example.org|
|Sub-Investigator: Katharine Hinchcliff, MD|
|Principal Investigator:||Robert M Szabo, MD, MPH||University of California, Davis|