Post Operative Dressing After Clean Elective Hand Surgery

NCT04268095 | Completed

• 1 other identifier: 0548-18-TLV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

No dressing change

EXPERIMENTAL

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

Other: Dressing protocol

Ambulatory dressing change

EXPERIMENTAL

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

No dressing

EXPERIMENTAL

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

Other: Dressing protocol

Interventions

Dressing protocol OTHER

Patients are assigned with different postoperative dressing protocols.

Ambulatory dressing change; No dressing; No dressing change

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Itay Ashkenazi: lead

Study Sites (1)

Tel Aviv medical cemter

Tel Aviv, IL, 6423906, Israel

Location

MeSH Terms

Conditions

Trigger Finger Disorder; Carpal Tunnel Syndrome; Ganglion Cysts

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Cysts; Neoplasms; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 13, 2020
• Study Start: December 31, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 30 days
• Access Criteria: at the discretion of the Chief Investigator

Locations

IL (1)