Skin TransplantationNCT07112898
Effect of Platelet-Rich Plasma on Graft Uptake and Postoperative Outcomes in Full-Thickness Skin Grafting of Face and Neck
A study testing Platelet-Rich Plasma (PRP) and Standard Skin Grafting in people with Skin Transplantation and Reconstructive Surgical Procedures, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
This clinical study aims to evaluate whether applying platelet-rich plasma (PRP), a substance made from a person's own blood, can improve the success of full-thickness skin grafts used to treat facial and neck wounds. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Transplantation, Reconstructive Surgical Procedures
- What is being tested?
- Platelet-Rich Plasma (PRP) and Standard Skin Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years undergoing full-thickness skin grafting for facial or cervical skin defects.
- Indications for grafting include post-traumatic defects, burns, tumor excision, or revision surgeries.
- Patients with wound defects of size ranging between 3 cm² and 6 cm², amenable to single-session full-thickness skin grafting.
- Patients in whom the recipient bed is healthy, vascularized, and free of necrotic tissue at the time of surgery.
Who cannot join
- Patients with systemic conditions known to impair wound healing, including uncontrolled diabetes mellitus (HbA1c >8%), severe peripheral vascular disease, collagen vascular disorders, or immunodeficiency.
- Patients with hematological disorders affecting platelet count or function, including thrombocytopenia (platelet count <150,000/µL), coagulopathies, or platelet dysfunction syndromes.
- Patients on systemic anticoagulation therapy (e.g., warfarin, DOACs) or corticosteroids within the last 4 weeks.
- Presence of active local infection or purulent discharge at the recipient or donor site at the time of surgery.
- History of previous radiation to the grafted site or underlying malignancy with ongoing treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
This clinical study aims to evaluate whether applying platelet-rich plasma (PRP), a substance made from a person's own blood, can improve the success of full-thickness skin grafts used to treat facial and neck wounds. Skin grafting is a common reconstructive technique for covering wounds caused by injuries, burns, surgeries, or other conditions. However, skin grafts sometimes do not heal well, leading to complications such as graft failure, infection, or delayed healing, especially in delicate areas like the face and neck.
Platelet-rich plasma contains special healing components called growth factors that may help tissues heal faster and better. These growth factors support new blood vessel formation, reduce swelling, and promote healthy skin regeneration. In this study, participants will be randomly assigned to one of two groups. One group will receive skin grafts along with PRP applied to the wound and graft site, while the other group will receive standard grafting without PRP.
The study will measure how much of the graft survives and integrates into the wound (called "graft uptake") on the 7th day after surgery. It will also assess other early outcomes such as signs of redness (erythema), infection, or blood collection under the graft (hematoma). The hypothesis is that using PRP will lead to better graft healing and fewer complications than using skin grafts alone. The results of this study may help improve recovery and reduce the need for further procedures in patients with facial and neck skin defects.
- Being tested
- Platelet-Rich Plasma (PRP), Standard Skin Grafting
- Keywords
- Full-Thickness Skin Graft, Platelet-Rich Plasma, Wound Healing Enhancement, Graft Uptake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP)Procedure or surgery
Also called Autologous PRP
Autologous PRP (approximately 4-6 mL) will be prepared using a double centrifugation technique and activated with 10% calcium gluconate. It will be administered by injecting 0.1-0.2 mL/cm² subdermally into the recipient bed and intradermally into the graft prior to placement.
Standard Skin GraftingProcedure or surgery
Also called Conventional Full-Thickness Skin Graft
Grafts will be placed on a clean, vascularized wound bed, secured with nonabsorbable sutures, and covered with standard postoperative dressings. No PRP will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Group PRP | Experimental | Patients in this group received autologous platelet-rich plasma (PRP) applied to both the recipient wound bed and the graft before graft placement, during full-thickness skin grafting for facial or neck defects. Receives: Procedure: Platelet-Rich Plasma (PRP) |
| Group Control | Active comparator | Patients in this group underwent standard full-thickness skin grafting on the face or neck without PRP application. Receives: Procedure: Standard Skin Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Graft Uptake at Day 7 Postoperatively
Graft uptake will be assessed as the percentage of the original wound area successfully covered by the viable graft on the 7th postoperative day. This will be calculated using the formula:
Graft Uptake (%) = [(Original wound area - Denuded area) ÷ Original wound area] × 100.
The denuded area will be determined using sterile measurement tools such as a surgical ruler, grid tracing, or digital planimetry. Based on the uptake percentage, the graft will be categorized qualitatively as: Excellent (>90%), Good (76-90%), Moderate (50-75%), Poor (<50%), or Failed (0%).
Measured: 7th postoperative day
Secondary outcomes (2)
Proportion of Patients with Graft Failure (0% Uptake)
Graft failure will be defined as complete necrosis or detachment of the graft, resulting in 0% uptake on the 7th postoperative day. Failure will be confirmed through clinical evaluation and photographic documentation.
Measured: 7th postoperative day
Local Graft Site Infection
Infection will be diagnosed if at least two of the following signs are present: purulent discharge, localized swelling, increased warmth, or breakdown at the graft margins. Evaluation will be performed by the surgical team, and swabs may be collected if purulent discharge is observed.
Measured: 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Jul 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TransplantationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112898
- Sponsor's protocol ID
- LahoreGeneralH5
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet-Rich Plasma on Graft Uptake and Postoperative Outcomes in Full-Thickness Skin Grafting of Face and Neck
- ClinicalTrials.gov ID
- NCT07112898
- Acronym / sponsor ID
- LahoreGeneralH5
- Keywords
- Full-Thickness Skin Graft, Platelet-Rich Plasma, Wound Healing Enhancement, Graft Uptake
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 8 Aug 2025 (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.
This clinical study aims to evaluate whether applying platelet-rich plasma (PRP), a substance made from a person's own blood, can improve the success of full-thickness skin grafts used to treat facial and neck wounds. Skin grafting is a common reconstructive technique for covering wounds caused by injuries, burns, surgeries, or other conditions. However, skin grafts sometimes do not heal well, leading to complications such as graft failure, infection, or delayed healing, especially in delicate areas like the face and neck.
Platelet-rich plasma contains special healing components called growth factors that may help tissues heal faster and better. These growth factors support new blood vessel formation, reduce swelling, and promote healthy skin regeneration. In this study, participants will be randomly assigned to one of two groups. One group will receive skin grafts along with PRP applied to the wound and graft site, while the other group will receive standard grafting without PRP.
The study will measure how much of the graft survives and integrates into the wound (called "graft uptake") on the 7th day after surgery. It will also assess other early outcomes such as signs of redness (erythema), infection, or blood collection under the graft (hematoma). The hypothesis is that using PRP will lead to better graft healing and fewer complications than using skin grafts alone. The results of this study may help improve recovery and reduce the need for further procedures in patients with facial and neck skin defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PRP | Experimental | Procedure: Platelet-Rich Plasma (PRP)Patients in this group received autologous platelet-rich plasma (PRP) applied to both the recipient wound bed and the graft before graft placement, during full-thickness skin grafting for facial or neck defects. |
| Group Control | Active comparator | Procedure: Standard Skin GraftingPatients in this group underwent standard full-thickness skin grafting on the face or neck without PRP application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 65 years undergoing full-thickness skin grafting for facial or cervical skin defects.
- Indications for grafting include post-traumatic defects, burns, tumor excision, or revision surgeries.
- Patients with wound defects of size ranging between 3 cm² and 6 cm², amenable to single-session full-thickness skin grafting.
- Patients in whom the recipient bed is healthy, vascularized, and free of necrotic tissue at the time of surgery.
Key exclusion criteria (5 listed)
- Patients with systemic conditions known to impair wound healing, including uncontrolled diabetes mellitus (HbA1c >8%), severe peripheral vascular disease, collagen vascular disorders, or immunodeficiency.
- Patients with hematological disorders affecting platelet count or function, including thrombocytopenia (platelet count <150,000/µL), coagulopathies, or platelet dysfunction syndromes.
- Patients on systemic anticoagulation therapy (e.g., warfarin, DOACs) or corticosteroids within the last 4 weeks.
- Presence of active local infection or purulent discharge at the recipient or donor site at the time of surgery.
- History of previous radiation to the grafted site or underlying malignancy with ongoing treatment.
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 |
|---|---|---|
| Platelet-Rich Plasma (PRP)Also: Autologous PRPAutologous PRP (approximately 4-6 mL) will be prepared using a double centrifugation technique and activated with 10% calcium gluconate. It will be administered by injecting 0.1-0.2 mL/cm² subdermally into the recipient bed and intradermally into the graft prior to placement. | Procedure or surgery | Group PRP |
| Standard Skin GraftingAlso: Conventional Full-Thickness Skin GraftGrafts will be placed on a clean, vascularized wound bed, secured with nonabsorbable sutures, and covered with standard postoperative dressings. No PRP will be applied. | Procedure or surgery | Group Control |
Primary outcome
Percentage of Graft Uptake at Day 7 Postoperatively
Time frame: 7th postoperative day
Graft uptake will be assessed as the percentage of the original wound area successfully covered by the viable graft on the 7th postoperative day. This will be calculated using the formula: Graft Uptake (%) = [(Original wound area - Denuded area) ÷ Original wound area] × 100. The denuded area will be determined using sterile measurement tools such as a surgical ruler, grid tracing, or digital planimetry. Based on the uptake percentage, the graft will be categorized qualitatively as: Excellent (>90%), Good (76-90%), Moderate (50-75%), Poor (<50%), or Failed (0%).
2 secondary outcomes
Proportion of Patients with Graft Failure (0% Uptake)
Time frame: 7th postoperative day
Local Graft Site Infection
Time frame: 7th postoperative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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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.
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 Platelet-Rich Plasma (PRP) and Standard Skin Grafting in people with Skin Transplantation and Reconstructive Surgical Procedures, run by Lahore General Hospital 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 4 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: enrolling by invitation, as of the sponsor's last update on 8 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Graft Uptake at Day 7 Postoperatively (time frame: 7th postoperative day). 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 8 Aug 2025.