Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2020
CompletedStudy Start
First participant enrolled
October 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedAugust 25, 2021
August 1, 2021
5 months
October 11, 2020
August 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30minutes
Study Arms (2)
Tumescent with adrenaline
ACTIVE COMPARATORskin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.
Tumescent without adrenaline
ACTIVE COMPARATORskin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hypertensive patients,
- Bleeding tendencies (Disorder),
- Immune-compromised,
- Familial history of bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mahak
Karachi, Sindh, 1234, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MahakA
Study Record Dates
First Submitted
October 11, 2020
First Posted
October 19, 2020
Study Start
October 17, 2020
Primary Completion
March 17, 2021
Study Completion
March 17, 2021
Last Updated
August 25, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share