Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
Primary Purpose
Bleeding Time
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
tumescent with adrenaline
tumescent without adrenaline
Sponsored by

About this trial
This is an interventional other trial for Bleeding Time
Eligibility 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
Sites / Locations
- Mahak
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tumescent with adrenaline
Tumescent without adrenaline
Arm Description
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.
Outcomes
Primary Outcome Measures
ordinal scale
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04590638
First Posted
October 11, 2020
Last Updated
August 21, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04590638
Brief Title
Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
Official Title
Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2020 (Actual)
Primary Completion Date
March 17, 2021 (Actual)
Study Completion Date
March 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Time
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tumescent with adrenaline
Arm Type
Active Comparator
Arm Description
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.
Arm Title
Tumescent without adrenaline
Arm Type
Active Comparator
Arm Description
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.
Intervention Type
Other
Intervention Name(s)
tumescent with adrenaline
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
tumescent without adrenaline
Intervention Description
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.
Primary Outcome Measure Information:
Title
ordinal scale
Description
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.
Time Frame
30minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Mahak
City
Karachi
State/Province
Sindh
ZIP/Postal Code
1234
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
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