Skin GraftNCT05907915
Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery
A study testing low level laser therapy in people with Skin Graft, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing following skin graft surgery. BACKGROUND: The skin graft is a beneficial reconstructive technique for accelerating wound healing .Managing donor site after graft harvesting is very important, and often, patients have more… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Graft
- What is being tested?
- low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Apr 2023
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients are both males and females.
- Their Age will be range between 20-40 years.
- All patients suffering from third degree burn with TBSA for burn will be ranged from 20% to 35%.
- All patients undergoing split thickness skin graft surgery.
- All patients will begin the treatment program from the 1st day post operative
- All patients enrolled to the study will have their informed consent.
- All patients have donor sites from the thigh.
Who cannot join
- • Patients with associated diseases (Diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.
- Patients taking medication that alter the healing process (e.g., corticosteroids, chemotherapy or radiation.
- Pregnancy or epilepsy.
- Elderly patients.
- Subjects who have photosensitive problems
- History of trauma or accidental injuries.
- Skin diseases.
- History of surgery on particular donor site.
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE:
The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing following skin graft surgery.
Read more
BACKGROUND:
The skin graft is a beneficial reconstructive technique for accelerating wound healing .Managing donor site after graft harvesting is very important, and often, patients have more discomfort at the donor site than the recipient burn site itself.Using techniques that accelerate wound healing may enhance patient satisfaction.
Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers.
Accelerating the healing process and reducing pain during healing are beneficial for the following reasons: faster return to work, lower risk of wound infection, improved quality of life, and possibly reduced need for analgesia.
HYPOTHESES:
It is hypothesized that:
Low level laser therapy has a positive effect on donor site wound healing following skin graft surgery in burned patients.
RESEARCH QUESTION:
Is low level laser therapy has a positive effect on donor site healing following skin graft surgery in burned patients?
- Conditions
- Skin Graft
- Being tested
- low level laser therapy, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyDevice
They recieved LLLT 1 session daily, 3 session per week for 3 weeks,with the following parameters( 650 nm wavelength, 150 mw power output, 0.25 cm2 radiation area, 0.6 W/cm2 power density, continuous mode, 2 j/ cm2, 90 seconds / cm2) in addition to the conventional medical treatment and traditional wound care (dressing)
placeboBehavioural
They received placebo laser 1 session daily, 3 session per week for 3 weeks in addition to the conventional medical treatment and traditional wound care (dressing)
| Study group | Role | What they receive |
|---|---|---|
| laser group | Experimental | active low level laser therapy and conventional medical treatment. Receives: Device: low level laser therapy |
| placebo group | Placebo comparator | placebo laser and conventional medical treatment Receives: Behavioral: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement)
Measurement of wound surface area by photography and image J software at day 1
Measured: 1 day
Measurement of wound surface area at day 11 post-operative (post-treatment)
Measurement of wound surface area by photography and image J software at day 11
Measured: 11 day
Measurement of wound surface area at day 21 post-operative (post-treatment)
Measurement of wound surface area by photography and image J software at day 21
Measured: 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin GraftStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohamed Kamel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907915
- Sponsor's protocol ID
- P.T.REC/012/003623
- Status last verified
- Dec 2022
- First submitted
- 6 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaghardoost R, Momeni M, Kazemikhoo N, Mokmeli S, Dahmardehei M, Ansari F, Nilforoushzadeh MA, Sabr Joo P, Mey Abadi S, Naderi Gharagheshlagh S, Sassani S. Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial). Lasers Med Sci. 2018 Apr;33(3):603-607. doi: 10.1007/s10103-017-2430-4. Epub 2018 Jan 24.
PubMed 29368069Assis L, Moretti AI, Abrahao TB, Cury V, Souza HP, Hamblin MR, Parizotto NA. Low-level laser therapy (808 nm) reduces inflammatory response and oxidative stress in rat tibialis anterior muscle after cryolesion. Lasers Surg Med. 2012 Nov;44(9):726-35. doi: 10.1002/lsm.22077. Epub 2012 Sep 21.
PubMed 23001637Huang J, Chen J, Xiong S, Huang J, Liu Z. The effect of low-level laser therapy on diabetic foot ulcers: A meta-analysis of randomised controlled trials. Int Wound J. 2021 Dec;18(6):763-776. doi: 10.1111/iwj.13577. Epub 2021 Mar 9.
PubMed 33751853Voineskos SH, Ayeni OA, McKnight L, Thoma A. Systematic review of skin graft donor-site dressings. Plast Reconstr Surg. 2009 Jul;124(1):298-306. doi: 10.1097/PRS.0b013e3181a8072f.
PubMed 19568092
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery
- ClinicalTrials.gov ID
- NCT05907915
- Acronym / sponsor ID
- P.T.REC/012/003623
- Conditions
- Skin Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Jun 2023 (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.
PURPOSE:
The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing following skin graft surgery.
BACKGROUND:
The skin graft is a beneficial reconstructive technique for accelerating wound healing .Managing donor site after graft harvesting is very important, and often, patients have more discomfort at the donor site than the recipient burn site itself.Using techniques that accelerate wound healing may enhance patient satisfaction.
Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers.
Accelerating the healing process and reducing pain during healing are beneficial for the following reasons: faster return to work, lower risk of wound infection, improved quality of life, and possibly reduced need for analgesia.
HYPOTHESES:
It is hypothesized that:
Low level laser therapy has a positive effect on donor site wound healing following skin graft surgery in burned patients.
RESEARCH QUESTION:
Is low level laser therapy has a positive effect on donor site healing following skin graft surgery in burned patients?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser group | Experimental | Device: low level laser therapyactive low level laser therapy and conventional medical treatment. |
| placebo group | Placebo comparator | Behavioral: placeboplacebo laser and conventional medical treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients are both males and females.
- Their Age will be range between 20-40 years.
- All patients suffering from third degree burn with TBSA for burn will be ranged from 20% to 35%.
- All patients undergoing split thickness skin graft surgery.
- All patients will begin the treatment program from the 1st day post operative
Key exclusion criteria (8 listed)
- • Patients with associated diseases (Diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.
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 |
|---|---|---|
| low level laser therapyThey recieved LLLT 1 session daily, 3 session per week for 3 weeks,with the following parameters( 650 nm wavelength, 150 mw power output, 0.25 cm2 radiation area, 0.6 W/cm2 power density, continuous mode, 2 j/ cm2, 90 seconds / cm2) in addition to the conventional medical treatment and traditional wound care (dressing) | Device | laser group |
| placeboThey received placebo laser 1 session daily, 3 session per week for 3 weeks in addition to the conventional medical treatment and traditional wound care (dressing) | Behavioural | placebo group |
Primary outcome
Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement)
Time frame: 1 day
Measurement of wound surface area by photography and image J software at day 1
Measurement of wound surface area at day 11 post-operative (post-treatment)
Time frame: 11 day
Measurement of wound surface area by photography and image J software at day 11
Measurement of wound surface area at day 21 post-operative (post-treatment)
Time frame: 21 day
Measurement of wound surface area by photography and image J software at day 21
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 18 Jun 2023.
- Background: PubMed 29368069Vaghardoost R, Momeni M, Kazemikhoo N, Mokmeli S, Dahmardehei M, Ansari F, Nilforoushzadeh MA, Sabr Joo P, Mey Abadi S, Naderi Gharagheshlagh S, Sassani S. Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial). Lasers Med Sci. 2018 Apr;33(3):603-607. doi: 10.1007/s10103-017-2430-4. Epub 2018 Jan 24.
- Background: PubMed 23001637Assis L, Moretti AI, Abrahao TB, Cury V, Souza HP, Hamblin MR, Parizotto NA. Low-level laser therapy (808 nm) reduces inflammatory response and oxidative stress in rat tibialis anterior muscle after cryolesion. Lasers Surg Med. 2012 Nov;44(9):726-35. doi: 10.1002/lsm.22077. Epub 2012 Sep 21.
- Background: PubMed 33751853Huang J, Chen J, Xiong S, Huang J, Liu Z. The effect of low-level laser therapy on diabetic foot ulcers: A meta-analysis of randomised controlled trials. Int Wound J. 2021 Dec;18(6):763-776. doi: 10.1111/iwj.13577. Epub 2021 Mar 9.
- Background: PubMed 19568092Voineskos SH, Ayeni OA, McKnight L, Thoma A. Systematic review of skin graft donor-site dressings. Plast Reconstr Surg. 2009 Jul;124(1):298-306. doi: 10.1097/PRS.0b013e3181a8072f.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Graft
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
Not yet recruiting
Full-Thickness Skin Graft Sizing and Scar Quality
Graft Healing
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 low level laser therapy in people with Skin Graft, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 8 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 18 Jun 2023. 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 Egypt. 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?
Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement) (time frame: 1 day). The study lists 3 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 NCT05907915, which also lists 4 linked publications.
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 18 Jun 2023.