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

Non-healing Wound Clinical Trial

Official title:

Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344483
• Other study ID #: 1506
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: June 10, 2020

Study information

• Verified date: November 2020
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 10, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-healing Wound

Intervention

Drug:
• 2% Lidocaine and 1:100,000 Adrenaline
Topical application of 2% Lidocaine and 1:100,000 Adrenaline in the form of dressing will be applied over skin graft donor site of thigh for 10 minutes.
• Normal saline
Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.

Locations

Country	Name	City	State
Pakistan	Zaara Zahid	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Gacto P, Miralles F, Pereyra JJ, Perez A, Martínez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009 May;35(3):343-7. doi: 10.1016/j.burns.2008.06.019. Epub 2008 Oct 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra operatieve bleeding	Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.	per operative
Primary	Post operative bleeding	post operative bleeding will be assesd in post operative period by number of dressings required.	24 hours
Primary	Post operative pain	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.	24 hours
Primary	Analgesia requirement	Post operative analgesia requirement of patient will be observed by number of medications required	24 hours
Secondary	Epithelization of donor site	Epithelization over donor site will be assessed on 14th post operative day by subjective assesment	14 days

External Links

•   Gacto P, Miralles F, Pereyra J, Perez A, Martinez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009;35(3):343-7.