Completed

Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial

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What is being tested

2% Lidocaine and 1:100,000 Adrenaline

+ Normal saline

Drug
Who is being recruted

Over 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2019
See protocol details

Summary

Principal SponsorDow University of Health Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 10, 2019

Actual date on which the first participant was enrolled.

After admission participants will be randomized either to be in Group A or Group B. Closed envelop technique will be used for random assignment of the patients. Group A will be receiving 2% lidocaine and 1:100,000 adrenaline soaked gauze while group B will be given only normal saline soaked gauze at donor-site for ten minutes. The primary end point of study is intraoperative bleeding. The secondary end points of study include no. of dressings required in first 24 hours after surgery, donor site epithelization at 14th post-operative day, post-operative pain in first 24 hours after surgery along with systemic analgesia requirement after surgery.

Official TitleEffect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial
NCT04344483
Principal SponsorDow University of Health Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * • Patients of both the gender of age \> 15 years * Multiple donor-sites Exclusion Criteria: Bleeding disorder * Concomitant injuries * Donor site other than thigh * Previously harvested donor-site * Patients on antiplatelet medications

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Group A patients will receive 2% Lidocaine and 1:100,000 adrenaline soaked gauze over skin graft donor site of thigh per operatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site.

Group II

Placebo
Group B patients will receive normal saline soaked gauze over skin graft donor site of thigh intraoperatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Zaara Zahid

Karachi, PakistanOpen Zaara Zahid in Google Maps
CompletedOne Study Center