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

NCT ID: NCT04590638

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-17

Study Completion Date

2021-03-17

Brief Summary

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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

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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

Conditions

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Bleeding Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tumescent with adrenaline

skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.

Group Type ACTIVE_COMPARATOR

tumescent with adrenaline

Intervention Type OTHER

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.

Tumescent without adrenaline

skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.

Group Type ACTIVE_COMPARATOR

tumescent without adrenaline

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mahak Ali

MahakA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mahak

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Mmehak

Identifier Type: -

Identifier Source: org_study_id

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