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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04268095
Other study ID # 0548-18-TLV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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