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Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.

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ClinicalTrials.gov Identifier: NCT04590638
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Mahak Ali, Dow University of Health Sciences

Study Description
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Brief Summary:
The purpose of this study is to appraise if various concentration of adrenaline containing tumescent has any significant role in bleeding at skin graft donor site bleeding through photographic assessment.

Condition or disease Intervention/treatment Phase
Bleeding Time Other: tumescent with adrenaline Other: tumescent without adrenaline Not Applicable

Detailed Description:

Tumescent solutions will be prepared by adding 30cc of Ringer's lactate and 10cc of lignocaine 2%, with 1cc of adrenaline of 1:200,000 (which will be prepared by adding 1cc of adrenaline of 1:1000 conc. with 200ml of normal saline marked as solution "A" and without adrenaline marked as solution "B" to form the two different tumescent solutions. Both solutions with be topically applied in soaked gauzes for around 10 minutes. Solution A will be applied over the anterior side of thigh while solution B will be applied over lateral side of thigh.

Tumescent solutions will be prepared around 10 minutes before applying. After 10 min Split-thickness skin graft donor sites will be harvested with a Dermatome adjusted on with a randomized setting to harvest a fixed depth of wound depth. After harvesting skin graft the donor site wound will be photographed.

The apparent severity of bleeding will be scored on an ordinal scale from 0 to 5 (0=no bleeding/staining, 1=minimal bleeding/staining, 2=mild bleeding/staining, 3=moderate bleeding/staining, 4=moderately severe bleeding/staining, 5=severe bleeding/staining by two independent surgeons. At last photographs will be compared with pre-infiltration records in each side. Skin graft donor and recipient site will be inspected on the 5th post-operative day

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
Actual Study Start Date : October 17, 2020
Actual Primary Completion Date : March 17, 2021
Actual Study Completion Date : March 17, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tumescent with adrenaline
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.
 Other: tumescent with adrenaline
skin graft donor site of patients enrolled in this group will be injected subcutaneously with tumescent solution containing adrenaline to see the bleeding control of donor site.
Active Comparator: Tumescent without adrenaline
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.
 Other: tumescent without adrenaline
skin graft donor site of patients enrolled in this group will be injected subcutaneously with tumescent solution not containing adrenaline to see the bleeding control of donor site.


Outcome Measures
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Primary Outcome Measures :
  1. ordinal scale [ Time Frame: 30minutes ]
    The apparent severity of bleeding will be scored on an ordinal scale from 0 to 5 (0=no bleeding/staining, 1=minimal bleeding/staining, 2=mild bleeding/staining, 3=moderate bleeding/staining, 4=moderately severe bleeding/staining, 5=severe bleeding/staining by two independent surgeons.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age above 18 years

    • both genders
    • non hypertensive patients
    • Hemoglobin levels more than 10 g/dl
    • Platelet count above 150 x 10E9/L
    • Wounds for more than 6 weeks

Exclusion Criteria:

  • • Hypertensive patients,

    • Bleeding tendencies (Disorder),
    • Immune-compromised,
    • Familial history of bleeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590638


Locations
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Pakistan
Mahak
Karachi, Sindh, Pakistan, 1234
Sponsors and Collaborators
Dow University of Health Sciences
More Information
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Responsible Party: Mahak Ali, MahakA, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT04590638    
Other Study ID Numbers: Mmehak
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents