Post Operative Dressing After Clean Elective Hand Surgery
Primary Purpose
Trigger Finger Disorder, Carpal Tunnel Syndrome, Ganglion
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dressing protocol
Sponsored by
About this trial
This is an interventional prevention trial for Trigger Finger Disorder
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.
Sites / Locations
- Tel Aviv medical cemter
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
No dressing change
Ambulatory dressing change
No dressing
Arm Description
Patients do not change dressing from procedure to first clinic followup after 14 days.
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
Patients take off dressing at post operative day 1 and clean it 3 times per day as instructed.
Outcomes
Primary Outcome Measures
Change in Instrumental activities of daily living questioner (IADL)
Subjective function questioner. Scale 0-18. Higher score - better outcome.
Change in Vancouver Scar Scale
Evaluation of skin healing and scar formation. Scale 0-14. Higher score - inferior outcome.
Change in quick Disability of the Arm, Shoulder and Hand questioner (DASH)
Subjective function questioner. Scale 0-100. Higher score - inferior outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04268095
Brief Title
Post Operative Dressing After Clean Elective Hand Surgery
Official Title
Post Operative Dressing After Clean Elective Hand Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Itay Ashkenazi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger Disorder, Carpal Tunnel Syndrome, Ganglion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No dressing change
Arm Type
Experimental
Arm Description
Patients do not change dressing from procedure to first clinic followup after 14 days.
Arm Title
Ambulatory dressing change
Arm Type
Experimental
Arm Description
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
Arm Title
No dressing
Arm Type
Experimental
Arm Description
Patients take off dressing at post operative day 1 and clean it 3 times per day as instructed.
Intervention Type
Other
Intervention Name(s)
Dressing protocol
Intervention Description
Patients are assigned with different postoperative dressing protocols.
Primary Outcome Measure Information:
Title
Change in Instrumental activities of daily living questioner (IADL)
Description
Subjective function questioner. Scale 0-18. Higher score - better outcome.
Time Frame
Baseline (Pre-op), 2 weeks, 6 weeks, 3 months
Title
Change in Vancouver Scar Scale
Description
Evaluation of skin healing and scar formation. Scale 0-14. Higher score - inferior outcome.
Time Frame
2 weeks, 6 weeks, 3 months
Title
Change in quick Disability of the Arm, Shoulder and Hand questioner (DASH)
Description
Subjective function questioner. Scale 0-100. Higher score - inferior outcome.
Time Frame
Baseline, 2 weeks, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Tel Aviv medical cemter
City
Tel Aviv
State/Province
IL
ZIP/Postal Code
6423906
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Post Operative Dressing After Clean Elective Hand Surgery
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