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

NCT03950401 | Completed

• 1 other identifier: 1386423
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

skin closure

Outcome Measures

Primary Outcomes (2)

• Patient and Observer Scar Assessment Scale (POSAS) Score - Patient

  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.

  6 weeks

• Patient and Observer Scar Assessment Scale (POSAS) Score - Observer

  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.

  6 weeks

Secondary Outcomes (1)

• Patient satisfaction

  6 weeks

Study Arms (2)

Monocryl

ACTIVE COMPARATOR

Closure of the skin at the completion of surgery by interrupted subcuticular technique with absorbable Monocryl suture.

Procedure: Monocryl

Nylon

ACTIVE COMPARATOR

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

Interventions

Monocryl PROCEDURE

subcuticular Monocryl wound closure

Monocryl

Nylon PROCEDURE

wound closure using nylon suture on the skin

Nylon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (4)

• Wade RG, Wormald JC, Figus A. Absorbable versus non-absorbable sutures for skin closure after carpal tunnel decompression surgery. Cochrane Database Syst Rev. 2018 Feb 1;2(2):CD011757. doi: 10.1002/14651858.CD011757.pub2.

  PMID: 29390170 BACKGROUND

• Menovsky T, Bartels RH, van Lindert EL, Grotenhuis JA. Skin closure in carpal tunnel surgery: a prospective comparative study between nylon, polyglactin 910 and stainless steel sutures. Hand Surg. 2004 Jul;9(1):35-8. doi: 10.1142/s0218810404002017.

  PMID: 15368623 BACKGROUND

• Hansen TB, Kirkeby L, Fisker H, Larsen K. Randomised controlled study of two different techniques of skin suture in endoscopic release of carpal tunnel. Scand J Plast Reconstr Surg Hand Surg. 2009;43(6):335-8. doi: 10.1080/02844310902955763.

  PMID: 19995253 BACKGROUND

• Fleisher J, Khalifeh A, Pettker C, Berghella V, Dabbish N, Mackeen AD. Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure. J Matern Fetal Neonatal Med. 2019 Nov;32(22):3830-3835. doi: 10.1080/14767058.2018.1474870. Epub 2018 May 24.

  PMID: 29739243 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

glycolide E-caprolactone copolymer; Nylons

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Robert M Szabo, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to Monocryl versus subcuticular Nylon type of skin closure.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: May 16, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)