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Completed

NCT Number: NCT04344483

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

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.

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Key information

Conditions

Non-healing Wound

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zaara Zahid

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

2% Lidocaine and 1:100,000 Adrenaline

Drug

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

Drug

Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.

Primary outcomes

  1. Intra operatieve bleeding

    Time frame: per operative

    Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.

  2. Post operative bleeding

    Time frame: 24 hours

    post operative bleeding will be assesd in post operative period by number of dressings required.

  3. Post operative pain

    Time frame: 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.

  4. Analgesia requirement

    Time frame: 24 hours

    Post operative analgesia requirement of patient will be observed by number of medications required

Secondary outcomes

  1. Epithelization of donor site

    Time frame: 14 days

    Epithelization over donor site will be assessed on 14th post operative day by subjective assesment

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Nov 10, 2020

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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