Post Operative Dressing After Clean Elective Hand Surgery

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)

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Trigger Finger Disorder; Ganglion
• Intervention / Treatment: Other: Dressing protocol

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • IL
    • Tel Aviv, IL, Israel, 6423906
      • Tel Aviv medical cemter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No dressing change; Patients do not change dressing from procedure to first clinic followup after 14 days.	Other: Dressing protocol; Patients are assigned with different postoperative dressing protocols.
Experimental: 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	Other: Dressing protocol; Patients are assigned with different postoperative dressing protocols.
Experimental: No dressing; Patients take off dressing at post operative day 1 and clean it 3 times per day as instructed.	Other: Dressing protocol; Patients are assigned with different postoperative dressing protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Itay Ashkenazi

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Tendinopathy; Tendon Entrapment; Carpal Tunnel Syndrome; Trigger Finger Disorder
• Other Study ID Numbers: 0548-18-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared at the discretion of the Chief Investigator
• IPD Sharing Time Frame: 30 days
• IPD Sharing Access Criteria: at the discretion of the Chief Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No