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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04590638

Enrollment

Registered

2020-10-19

Start date

2020-10-17

Completion date

2021-03-17

Last updated

2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Time

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

Interventions

OTHERtumescent 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.

OTHERtumescent 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
ordinal scale	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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026