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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
Itay Ashkenazi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trigger Finger Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 5, 2020
Last Updated
April 3, 2021
Sponsor
Itay Ashkenazi
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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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