- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04344483
Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh
Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial
Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh.
Haemostatic effect, epithelization and post operative pain will be assessed on follow up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Zaara Zahid
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A ( Lidocaine + Adrenaline)
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.
|
Topical application of 2% Lidocaine and 1:100,000 Adrenaline in the form of dressing will be applied over skin graft donor site of thigh for 10 minutes.
|
Placebo Comparator: Group B ( Normal Saline)
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
|
Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra operatieve bleeding
Time Frame: per operative
|
Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.
|
per operative
|
Post operative bleeding
Time Frame: 24 hours
|
post operative bleeding will be assesd in post operative period by number of dressings required.
|
24 hours
|
Post operative pain
Time Frame: 24 hours
|
post operative pain will be assessed in the post operative period by visual analog score.
Score ranges from 0 to 10 with 0 indicating no pain whereas 10 is worst pain.
|
24 hours
|
Analgesia requirement
Time Frame: 24 hours
|
Post operative analgesia requirement of patient will be observed by number of medications required
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epithelization of donor site
Time Frame: 14 days
|
Epithelization over donor site will be assessed on 14th post operative day by subjective assesment
|
14 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- 1506
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-healing Wound
-
Mayo ClinicRecruitingNon-healing Wound | Lower Extremity Wound | Non-Healing Ulcer of SkinUnited States
-
Kettering Health NetworkCompletedOpen Wound Abdominal Wall | Wound Non HealingUnited States
-
University of California, Los AngelesNot yet recruitingNon-healing Wound
-
Omeza, LLCRecruitingNon-healing Wound | Non-Healing Ulcer of SkinUnited States
-
Institute of Biophysics and Cell Engineering of...Minsk Scientific-Practical Center for Surgery, Transplantation and HematologyCompletedTreatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal FibroblastsNon-healing Wound | Trophic Ulcer | Non-Healing Ulcer of SkinBelarus
-
University of Witten/HerdeckeKCI Europe Holding B.V.CompletedImpaired Wound Healing | Wound Healing Disorder | Abdominal Wound Healing Disorder | Abdominal Wound Healing Impairment | Acute Postsurgical Subcutaneous WoundBelgium, Germany
-
Carmel Medical CenterUnknownNon-healing Wound | Infected Wound
-
Cardiff and Vale University Health BoardCardiff Metropolitan UniversityCompletedNon-healing Wound | Pilonidal AbscessUnited Kingdom
-
Henry M. Jackson Foundation for the Advancement...TerminatedNon-healing Soft Tissue WoundsUnited States
-
Roger Williams Medical CenterTerminatedNon Healing WoundsUnited States
Clinical Trials on 2% Lidocaine and 1:100,000 Adrenaline
-
University of TorontoUnknownChronic SinusitisCanada
-
Tusker MedicalCompletedHealthy VolunteerUnited States
-
University of North Carolina, Chapel HillCompletedPain | Anesthesia, LocalUnited States
-
University of MiamiCompletedBlepharoptosisUnited States
-
Duke UniversityWithdrawnUse of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's SurgeryUpper Eyelid SurgeryUnited States
-
University of Campinas, BrazilFundação de Amparo à Pesquisa do Estado de São PauloCompletedPain | Irreversible PulpitisBrazil
-
Stanford UniversityCompletedIntraoperative BleedingUnited States
-
Chinese University of Hong KongRecruitingMusculoskeletal Diseases or ConditionsHong Kong
-
Vanderbilt University Medical CenterNot yet recruitingSkin Cancer Face | Postoperative Bleeding
-
Ohio State UniversityCompleted