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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-healing Wound

Intervention / Treatment
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* Drug: 2% Lidocaine and 1:100,000 Adrenaline
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients with non healing wound who will otherwise be healthy will be recruited in the study and will randomly assign groups. One group will receive Adrenaline and Lidocaine soaked gauze and the second group will be a control group who will receive normal saline soaked gauze.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A ( Lidocaine + Adrenaline)<br>Group A patients will receive 2% Lidocaine and 1:100,000 adrenaline soaked gauze over skin graft donor site of thigh per operatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site. | Drug: 2% Lidocaine and 1:100,000 Adrenaline<br>* 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.<br>|
| Placebo Comparator: Group B ( Normal Saline)<br>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 | Drug: Normal saline<br>* Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Post operative bleeding | post operative bleeding will be assesd in post operative period by number of dressings required. | 24 hours | 
| 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 | 
| Analgesia requirement | Post operative analgesia requirement of patient will be observed by number of medications required | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelization of donor site | Epithelization over donor site will be assessed on 14th post operative day by subjective assesment | 14 days |