Post Operative Dressing After Clean Elective Hand Surgery

Carpal Tunnel Syndrome Clinical Trial

Official title:

Post Operative Dressing After Clean Elective Hand Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268095
• Other study ID #: 0548-18-TLV
• Status: Completed
• Phase: N/A
• Start date: December 31, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: Tel Aviv Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Very little has been published about the optimal post operative dressing protocol, and no practical conclusion has emerged from a meta-analysis published in 2013. Even fewer studies focused on that topic specifically in hand surgery. Nevertheless, the functional impairment due to a dressing in the hand is much greater than anywhere else, due to the constant use of hands in daily life activities. Yet, habits differs widely following surgeon's preference, from daily change with application of an antimicrobial unguent, to unchanged dressing until the first follow up consultation after 2 weeks, to complete removal of the dressing and basic soap and water cleaning at postoperative day (POD) 1. Those varying recommendations have functional and logistical implication for the patients, especially the elderlies, for whom autonomy is a fragile status that can be dramatically impaired by such protocols. The goal of this study is to define which post operative dressing protocol is optimal in terms of wound complications (disunion, infection)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective hand surgery with clean wound (Type 1 in wound classification of american college of surgeon 11) - (Carpal tunnel, trigger finger, cyst removal or foreign body removal, tendon release).

Exclusion Criteria:

• Insertion of hardware
• Known skin condition disturbing normal healing,
• Immunodeficiency,
• Incapacity to understand or to observe the self cleaning protocol.
• Unexpected peroperative complication leading to a modification of the operative technique.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Ganglion
• Trigger Finger Disorder

Intervention

Other:
• Dressing protocol
Patients are assigned with different postoperative dressing protocols.

Locations

Country	Name	City	State
Israel	Tel Aviv medical cemter	Tel Aviv	IL

Sponsors (1)

Lead Sponsor	Collaborator
Itay Ashkenazi

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Instrumental activities of daily living questioner (IADL)	Subjective function questioner. Scale 0-18. Higher score - better outcome.	Baseline (Pre-op), 2 weeks, 6 weeks, 3 months
Primary	Change in Vancouver Scar Scale	Evaluation of skin healing and scar formation. Scale 0-14. Higher score - inferior outcome.	2 weeks, 6 weeks, 3 months
Primary	Change in quick Disability of the Arm, Shoulder and Hand questioner (DASH)	Subjective function questioner. Scale 0-100. Higher score - inferior outcome.	Baseline, 2 weeks, 6 weeks, 3 months