Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh

Not Applicable

Completed

• Conditions: Non-healing Wound
• Interventions: Drug: Normal saline

• Registration Number: NCT04344483
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh.

Haemostatic effect, epithelization and post operative pain will be assessed on follow up.

Detailed Description

After admission participants will be randomized either to be in Group A or Group B. Closed envelop technique will be used for random assignment of the patients.

Group A will be receiving 2% lidocaine and 1:100,000 adrenaline soaked gauze while group B will be given only normal saline soaked gauze at donor-site for ten minutes.

The primary end point of study is intraoperative bleeding. The secondary end points of study include no. of dressings required in first 24 hours after surgery, donor site epithelization at 14th post-operative day, post-operative pain in first 24 hours after surgery along with systemic analgesia requirement after surgery.

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-07
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• • Patients of both the gender of age > 15 years

  • Multiple donor-sites

Exclusion Criteria

Bleeding disorder

• Concomitant injuries
• Donor site other than thigh
• Previously harvested donor-site
• Patients on antiplatelet medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B ( Normal Saline)	Normal saline	Group B patients will receive normal saline soaked gauze over skin graft donor site of thigh intraoperatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site

Primary Outcome Measures

Name	Time	Method
Intra operatieve bleeding	per operative	Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.
Post operative bleeding	24 hours	post operative bleeding will be assesd in post operative period by number of dressings required.
Analgesia requirement	24 hours	Post operative analgesia requirement of patient will be observed by number of medications required
Post operative pain	24 hours	post operative pain will be assessed in the post operative period by visual analog score. Score ranges from 0 to 10 with 0 indicating no pain whereas 10 is worst pain.

Secondary Outcome Measures

Name	Time	Method
Epithelization of donor site	14 days	Epithelization over donor site will be assessed on 14th post operative day by subjective assesment

Trial Locations

Locations (1)

Zaara Zahid; 🇵🇰 Karachi, Sindh, Pakistan