Post Operative Dressing After Clean Elective Hand Surgery

NCT ID: NCT04268095

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2021-02-01

Brief 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)

Conditions

Trigger Finger Disorder; Carpal Tunnel Syndrome; Ganglion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

No dressing change

Patients do not change dressing from procedure to first clinic followup after 14 days.

Group Type: EXPERIMENTAL

Dressing protocol

Intervention Type: OTHER

Patients are assigned with different postoperative dressing protocols.

Ambulatory dressing change

Patients change dressing by an ambulatory nurse (not associated with the study) 2 times a week from surgery to first clinic followup after 14 days

Group Type: EXPERIMENTAL

Dressing protocol

Intervention Type: OTHER

Patients are assigned with different postoperative dressing protocols.

No dressing

Patients take off dressing at post operative day 1 and clean it 3 times per day as instructed.

Group Type: EXPERIMENTAL

Dressing protocol

Intervention Type: OTHER

Patients are assigned with different postoperative dressing protocols.

Interventions

Dressing protocol

Patients are assigned with different postoperative dressing protocols.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Itay Ashkenazi

OTHER

Sponsor Role: lead

Responsible Party

Itay Ashkenazi

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tel Aviv medical cemter

Tel Aviv, IL, Israel

Countries

Israel

Other Identifiers

0548-18-TLV

Identifier Type: -

Identifier Source: org_study_id