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

Not Applicable

Completed

• Conditions: Bleeding Time
• Interventions: Other: tumescent with adrenaline; Other: tumescent without adrenaline

• Registration Number: NCT04590638
• Lead Sponsor: Dow University of Health Sciences

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

Study Timeline

• Study First Submitted: 2020-10-11
• Study First Submitted QC: 2020-10-11
• Study Start: 2020-10-17
• Study First Posted: 2020-10-19
• Primary Completion: 2021-03-17
• Study Completion: 2021-03-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tumescent with adrenaline	tumescent with adrenaline	skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.
Tumescent without adrenaline	tumescent without adrenaline	skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mahak; 🇵🇰 Karachi, Sindh, Pakistan