Non-healing WoundNCT04344483
Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh
A study testing 2% Lidocaine and 1:100,000 Adrenaline and Normal saline in people with Non-healing Wound, run by Dow University of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-healing Wound
- What is being tested?
- 2% Lidocaine and 1:100,000 Adrenaline and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2019to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Patients of both the gender of age > 15 years
- Multiple donor-sites
Who cannot join
- Bleeding disorder
- Concomitant injuries
- Donor site other than thigh
- Previously harvested donor-site
- Patients on antiplatelet medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Non-healing Wound
- Being tested
- 2% Lidocaine and 1:100,000 Adrenaline, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine and 1:100,000 AdrenalineDrug
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 salineDrug
Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( Lidocaine + Adrenaline) | Active comparator | 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. Receives: Drug: 2% Lidocaine and 1:100,000 Adrenaline |
| Group B ( Normal Saline) | Placebo comparator | 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra operatieve bleeding
Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.
Measured: per operative
Post operative bleeding
post operative bleeding will be assesd in post operative period by number of dressings required.
Measured: 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.
Measured: 24 hours
Analgesia requirement
Post operative analgesia requirement of patient will be observed by number of medications required
Measured: 24 hours
Secondary outcomes (1)
Epithelization of donor site
Epithelization over donor site will be assessed on 14th post operative day by subjective assesment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start10 Dec 2019
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-healing WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaara Zahid, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344483
- Sponsor's protocol ID
- 1506
- Status last verified
- Nov 2020
- First submitted
- 9 Apr 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gacto P, Miralles F, Pereyra JJ, Perez A, Martinez 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.
PubMed 18950945
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04344483
- Acronym / sponsor ID
- 1506
- Conditions
- Non-healing Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A ( Lidocaine + Adrenaline) | Active comparator | Drug: 2% Lidocaine and 1:100,000 AdrenalineGroup 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. |
| Group B ( Normal Saline) | Placebo comparator | Drug: Normal salineGroup 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients of both the gender of age > 15 years
Key exclusion criteria (5 listed)
- Bleeding disorder
- Concomitant injuries
- Donor site other than thigh
- Previously harvested donor-site
- Patients on antiplatelet medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Lidocaine and 1:100,000 AdrenalineTopical 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. | Drug | Group A ( Lidocaine + Adrenaline) |
| Normal salineTopical application of Normal saline will be applied over skin graft donor site of thigh as a control group. | Drug | Group B ( Normal Saline) |
Primary outcome
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.
Post operative bleeding
Time frame: 24 hours
post operative bleeding will be assesd in post operative period by number of dressings required.
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.
Analgesia requirement
Time frame: 24 hours
Post operative analgesia requirement of patient will be observed by number of medications required
1 secondary outcome
Epithelization of donor site
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Results publication: PubMed 18950945Gacto P, Miralles F, Pereyra JJ, Perez A, Martinez 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Lidocaine and 1:100,000 Adrenaline and Normal saline in people with Non-healing Wound, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra operatieve bleeding (time frame: per operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.