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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04344483
Enrollment
60
Registered
2020-04-14
Start date
2019-12-10
Completion date
2020-06-10
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-healing Wound

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.

Interventions

DRUG2% 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.

DRUGNormal saline

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

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients will be recruited in the study by closed envelope technique and the study will be single blinded.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intra operatieve bleedingper operativeIntra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.
Post operative bleeding24 hourspost operative bleeding will be assesd in post operative period by number of dressings required.
Post operative pain24 hourspost 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.
Analgesia requirement24 hoursPost operative analgesia requirement of patient will be observed by number of medications required

Secondary

MeasureTime frameDescription
Epithelization of donor site14 daysEpithelization over donor site will be assessed on 14th post operative day by subjective assesment

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026