Hair Loss/BaldnessNCT05984862
Role of Bandage After FUE Hair Transplantation
A study testing Bandage in people with Hair Loss/Baldness, run by Pak Medical and Diagnostic Center.
Trial summary
The aim of this interventional study is to determine the role of bandage on the follicular donor sites on the scalp after FUE hair transplantation. A randomized side of the scalp will be covered using bandage, the other side will be left naked. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hair Loss/Baldness
- What is being tested?
- Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Able to provide informed consent
- Planning to undergo follicular unit extraction hair restoration
Who cannot join
- Significant medical or surgical conditions
- Unable to give informed consent
- Immunocompromised
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation
The aim of this interventional study is to determine the role of bandage on the follicular donor sites on the scalp after FUE hair transplantation.
A randomized side of the scalp will be covered using bandage, the other side will be left naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and day 7 post-procedure during the healing phase. This will in turn help, answering the importance of bandage in healing of the donor site post-hair transplantation.
Read the detailed description
In this modern era, hair-transplantation has become very common. Interests in wound healing is not new; with every passing day, different techniques are introduced to get better results for the patients. The current literature available online shows that many hair-transplant centers have stated about using bandage on the donor area post-transplantation, however, there isn't a single study available to augment this use of bandage. On the other hand, data regarding application of antibiotic ointments and silicon gels is available. The punctures made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood supply of the scalp also favors quick healing. The process of re-epithelization starts within a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove, the bandage after 24hrs, disrupting the healing process of the skin. In the present study, the investigators sought to compare bandage versus no-Bandage donor site in terms of healing. The investigators hypothesize that, compared with bandage site, no-bandage donor site after FUE will have reduce post-procedural downtime and donor site inflammation ultimately, enhancing patient satisfaction with the procedure. The long-term goal of this study is to get evidence-based usage of bandage, if results are in contrast with the hypothesis.
- Conditions
- Hair Loss/Baldness
- Being tested
- Bandage
- Keywords
- Hair Loss, Follicular Unit Extraction, Hair transplantation, Wound healing
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BandageDevice
Also called wound healing
To determine if using bandage versus no-bandage, plays a role in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment left | Experimental | A randomized side of the scalp will be covered with bandage, the other side with no bandage.
Intervention: Device: Treatment - Bandage Receives: Device: Bandage |
| Experimental: Treatment right | Experimental | A randomized side of the scalp will be covered with bandage, the other side with no bandage.
Intervention: Device: Treatment - Bandage Receives: Device: Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
Bandage has protection role to some extent; however, removal of bandage will affect the normal healing of donor site. Healing Response (4-point ordinal scale) LEFT SIDE
- Not healed at all (0%)
- Mildly healed (33%)
- Moderately healed (66%)
- Completely healed (100%)
RIGHT SIDE
- Not healed at all (0%)
- Mild healing (33%)
- Moderately healed (66%)
- Completely healed (100%)
Measured: duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair Loss/BaldnessStudies 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
- This is a single center, triple-blind, within subject split scalp study investigating the comparison of bandage versus no bandage donor site post FUE. Twenty-five subjects desiring to undergo FUE for hair restoration will have bandage on one half of the donor area on the back of the scalp and no-bandage on the other side for 24 hours post procedure. The sides of the scalp will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Medical and Diagnostic Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Sarfraz Khan, Pak Medical and Diagnostic Center
- Investigators
- Muhammad Sarfraz Khan, BSc, MBBS, Study director, Pak Medical and Diagnostic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984862
- Sponsor's protocol ID
- PMDC-23-07-6745
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation
- ClinicalTrials.gov ID
- NCT05984862
- Acronym / sponsor ID
- PMDC-23-07-6745
- Conditions
- Hair Loss/Baldness
- Keywords
- Hair Loss, Follicular Unit Extraction, Hair transplantation, Wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Pak Medical and Diagnostic CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 9 Aug 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.
The aim of this interventional study is to determine the role of bandage on the follicular donor sites on the scalp after FUE hair transplantation.
A randomized side of the scalp will be covered using bandage, the other side will be left naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and day 7 post-procedure during the healing phase. This will in turn help, answering the importance of bandage in healing of the donor site post-hair transplantation.
Detailed description
In this modern era, hair-transplantation has become very common. Interests in wound healing is not new; with every passing day, different techniques are introduced to get better results for the patients. The current literature available online shows that many hair-transplant centers have stated about using bandage on the donor area post-transplantation, however, there isn't a single study available to augment this use of bandage. On the other hand, data regarding application of antibiotic ointments and silicon gels is available. The punctures made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood supply of the scalp also favors quick healing. The process of re-epithelization starts within a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove, the bandage after 24hrs, disrupting the healing process of the skin. In the present study, the investigators sought to compare bandage versus no-Bandage donor site in terms of healing. The investigators hypothesize that, compared with bandage site, no-bandage donor site after FUE will have reduce post-procedural downtime and donor site inflammation ultimately, enhancing patient satisfaction with the procedure. The long-term goal of this study is to get evidence-based usage of bandage, if results are in contrast with the hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single center, triple-blind, within subject split scalp study investigating the comparison of bandage versus no bandage donor site post FUE. Twenty-five subjects desiring to undergo FUE for hair restoration will have bandage on one half of the donor area on the back of the scalp and no-bandage on the other side for 24 hours post procedure. The sides of the scalp will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment left | Experimental | Device: BandageA randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage |
| Experimental: Treatment right | Experimental | Device: BandageA randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Able to provide informed consent
- Planning to undergo follicular unit extraction hair restoration
Key exclusion criteria (3 listed)
- Significant medical or surgical conditions
- Unable to give informed consent
- Immunocompromised
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 |
|---|---|---|
| BandageAlso: wound healingTo determine if using bandage versus no-bandage, plays a role in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure | Device | Experimental: Treatment left, Experimental: Treatment right |
Primary outcome
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
Time frame: duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites
Bandage has protection role to some extent; however, removal of bandage will affect the normal healing of donor site. Healing Response (4-point ordinal scale) LEFT SIDE * Not healed at all (0%) * Mildly healed (33%) * Moderately healed (66%) * Completely healed (100%) RIGHT SIDE * Not healed at all (0%) * Mild healing (33%) * Moderately healed (66%) * Completely healed (100%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Muhammad Sarfraz Khan, BSc, MBBS study director
Pak Medical and Diagnostic Center
Questions about this trial
What is this clinical trial studying?
A study testing Bandage in people with Hair Loss/Baldness, run by Pak Medical and Diagnostic Center.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jawad Jahangir, MBBS, FCPS,ABHRS (+923205636745, j.jabbasi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1) (time frame: duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.