Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT

Sponsor

East Avenue Medical Center, Philippines (Other)

Overall Status

Completed

CT.gov ID

NCT04491656

Collaborator

(none)

Enrollment

Location

Arms

18.4

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Further studies are needed to establish the effects of WALANT in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore, this study aims to identify the best interval time to perform elective hand surgeries using WALANT technique, document clinical outcomes and identify potential complications

Condition or Disease	Intervention/Treatment	Phase
Hand Surgery Orthopedic Surgery	Other: WALANT Technique	N/A

Detailed Description

To propose the optimal time delay from the injection to skin incision for most WALANT surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also postoperative pain scores and complication rates

To determine if there is a difference between performing the WALANT technique with a waiting interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss, pain scores, and complications.

Initiate the use of WALANT technique and its application in practice of Orthopaedic Residents in East Avenue Medical Center

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT: a Prospective Series of 34 Patients From a Low Resource Tertiary Setting

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jul 15, 2020

Actual Study Completion Date :

Jul 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 7 minutes group surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision	Other: WALANT Technique A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet
Active Comparator: 30 minutes group surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision	Other: WALANT Technique A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet

Arm

Intervention/Treatment

Active Comparator: 7 minutes group

surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision

Other: WALANT Technique

A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet

Active Comparator: 30 minutes group

surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision

Other: WALANT Technique

A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet

Outcome Measures

Primary Outcome Measures

VRS Score [24 weeks]
Verbal Rating Scale 0 for no pain 1 for mild pain 2 for moderate pain 3 for severe pain 4 for very severe pain

Secondary Outcome Measures

Blood Loss [24 weeks]
Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.

Other Outcome Measures

Complications [24 weeks]
Complications which may occur during the course of treatment and subsequent follow up of the patients which includes: wound complications, infection, stiffness, pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

. Signed Consent Form
Elective Hand Surgeries
Minor Hand Surgeries
Adult Male/Female ages 18 and above
Multiply injured

Exclusion Criteria:

No Consent
Multiply injured patient
Traumatic Hand Injuries
Known allergic reaction to either Epinephrine or Lidocaine.
Known heart condition
Patients on anticoagulants
Patients diagnosed with bleeding disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Avenue Medical Center; Department of Orthopedics	Quezon City		Philippines

Sponsors and Collaborators

East Avenue Medical Center, Philippines

Investigators

Study Chair: Mamer S. Rosario, MD, East Avenue Medical Center, Department of Orthopedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alvin A. Hernandez, Principal Investigator, East Avenue Medical Center, Philippines

ClinicalTrials.gov Identifier:

NCT04491656

Other Study ID Numbers:

EAMC IERB 2020 - 03

First Posted:

Jul 29, 2020

Last Update Posted:

Jul 29, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 29, 2020