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Completed

NCT Number: NCT04590638

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahak

Karachi, Sindh, 1234, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tumescent with adrenaline

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

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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