Graft HealingNCT07896317
Full-Thickness Skin Graft Sizing and Scar Quality
A study testing Full-Thickness Skin Graft Sizing in people with Graft Healing, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will compare three different full-thickness skin graft sizes (90%, 100%, and 110% of the surgical defect size) in patients undergoing reconstruction of nasal or ear surgical defects. Participants will be randomly assigned to one of the three graft sizes and followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graft Healing
- What is being tested?
- Full-Thickness Skin Graft Sizing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2026to 15 Mar 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing dermatologic surgery resulting in a nasal or auricular defect appropriate for full-thickness skin graft reconstruction
- Able to provide informed consent
- Willing and able to complete required study follow-up and photography
Who cannot join
- Age younger than 18 years
- Prisoners
- Pregnant women
- Non-English-speaking individuals
- Concurrent enrollment in another ongoing interventional trial
- UAB students or employees
Show all 12Show fewer
- History of keloids or clinically significant hypertrophic scarring
- Immunosuppression judged to significantly impair wound healing
- Prior radiation therapy involving the recipient site
- Active infection at the recipient site
- Unable or unwilling to complete required follow-up
- Any condition that, in the investigator's judgment, would significantly impair wound healing or make participation inappropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UAB Whitaker Clinic
Birmingham, Alabama, 35233
Matt Smith, 205-975-3015, josephmsmith@uabmc.edu
Aunna Pourang, MD, 2056451151, apourang@uabmc.edu
About this study
Official title: Effect of Full Thickness Skin Graft Size Relative to Recipient Defect on Scar Quality: A Prospective Randomized Observer-Blinded Study
This study will compare three different full-thickness skin graft sizes (90%, 100%, and 110% of the surgical defect size) in patients undergoing reconstruction of nasal or ear surgical defects. Participants will be randomly assigned to one of the three graft sizes and followed for 12 months. The study will evaluate scar quality, graft contraction, cosmetic outcomes, patient satisfaction, and complications to determine whether graft size affects healing and final appearance.
- Conditions
- Graft Healing
- Being tested
- Full-Thickness Skin Graft Sizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Thickness Skin Graft SizingProcedure or surgery
Participants will undergo full-thickness skin graft reconstruction using a graft harvested at 90%, 100%, or 110% of the measured recipient defect dimensions, according to randomized treatment assignment. Graft harvest, preparation, inset, fixation, donor-site selection, and postoperative wound care will otherwise follow routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 90% Graft Size | Experimental | Participants will receive a full-thickness skin graft harvested at 90% of the measured recipient defect dimensions. Receives: Procedure: Full-Thickness Skin Graft Sizing |
| 100% Graft Size | Active comparator | Participants will receive a full-thickness skin graft harvested at 100% of the measured recipient defect dimensions. Receives: Procedure: Full-Thickness Skin Graft Sizing |
| 110% Graft Size | Experimental | Participants will receive a full-thickness skin graft harvested at 110% of the measured recipient defect dimensions. Receives: Procedure: Full-Thickness Skin Graft Sizing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS) Scores
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS), version 2.0. The patient and observer scales each contain six items scored from 1-10, (patient: pain, itching, color, stiffness, thickness, irregularity/observer: vascularity, pigmentation, thickness, relief, pliability, surface area) yielding separate total scores ranging from 6 to 60. Higher scores indicate worse scar quality; lower scores indicate better scar quality. "Overall opinion ratings" are excluded from the total scores. Patient and observer total scores will be compared among the 90%, 100%, and 110% full-thickness skin graft sizing groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Graft HealingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conway Huang, University of Alabama at Birmingham
- Investigators
- Conway Huang, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896317
- Sponsor's protocol ID
- STUDY00000042
- Other IDs
- UAB
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be routinely shared due to participant privacy and confidentiality considerations, including the use of clinical photographs.
Publications
Liu J, Qu L, Song B. A comparative study of full-thickness skin grafting with and without subcutaneous fat preservation. Int Wound J. 2023 Apr;20(4):1160-1167. doi: 10.1111/iwj.13975. Epub 2022 Nov 3.
PubMed 36330586Shin J, Jang U, Baek SO, Lee JY. Full-Thickness Skin Graft according to Surrounding Relaxed Skin Tension Line Improves Scar Quality in Facial Defect Coverage: A Retrospective Comparative Study. Biomed Res Int. 2021 Sep 15;2021:7398090. doi: 10.1155/2021/7398090. eCollection 2021.
PubMed 34568495Stekelenburg CM, Simons JM, Tuinebreijer WE, van Zuijlen PP. Analyzing contraction of full thickness skin grafts in time: Choosing the donor site does matter. Burns. 2016 Nov;42(7):1471-1476. doi: 10.1016/j.burns.2016.02.001. Epub 2016 Aug 9.
PubMed 27520711Seo DH, Shin JY, Roh SG, Chang SC, Lee NH. A Comparative Assessment of Scars Resulting From Skin Grafts in Facial Defects. J Craniofac Surg. 2022 Jan-Feb 01;33(1):303-306. doi: 10.1097/SCS.0000000000007684.
PubMed 34967526Zilinsky I, Farber N, Weissman O, Israeli H, Haik J, Domniz N, Winkler E. Defying consensus: correct sizing of full-thickness skin grafts. J Drugs Dermatol. 2012 Apr;11(4):520-3.
PubMed 22453591Vathulya M, Rao S, Malik A, Sinha S, Kumar N, Kapoor A, Bahurupi Y. Is "Initial Size of the Graft the Real Culprit behind Primary Contraction of Full-Thickness Skin Graft"? - A Cross-Sectional Study. Arch Plast Surg. 2023 Feb 6;50(1):106-115. doi: 10.1055/s-0042-1756297. eCollection 2023 Jan.
PubMed 36755654Tuncali D, Yavuz N, Cigsar B, Gokrem S, Aslan G. Effect of full-thickness skin graft initial dimension on secondary wound contraction: experimental study in rats. Dermatol Surg. 2005 May;31(5):542-5. doi: 10.1111/j.1524-4725.2005.31158.
PubMed 15962738Andreassi A, Bilenchi R, Biagioli M, D'Aniello C. Classification and pathophysiology of skin grafts. Clin Dermatol. 2005 Jul-Aug;23(4):332-7. doi: 10.1016/j.clindermatol.2004.07.024.
PubMed 16023927
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Full Thickness Skin Graft Size Relative to Recipient Defect on Scar Quality: A Prospective Randomized Observer-Blinded Study
- ClinicalTrials.gov ID
- NCT07896317
- Acronym / sponsor ID
- STUDY00000042
- Conditions
- Graft Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 27 Oct 2026 (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 study will compare three different full-thickness skin graft sizes (90%, 100%, and 110% of the surgical defect size) in patients undergoing reconstruction of nasal or ear surgical defects. Participants will be randomly assigned to one of the three graft sizes and followed for 12 months. The study will evaluate scar quality, graft contraction, cosmetic outcomes, patient satisfaction, and complications to determine whether graft size affects healing and final appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 90% Graft Size | Experimental | Procedure: Full-Thickness Skin Graft SizingParticipants will receive a full-thickness skin graft harvested at 90% of the measured recipient defect dimensions. |
| 100% Graft Size | Active comparator | Procedure: Full-Thickness Skin Graft SizingParticipants will receive a full-thickness skin graft harvested at 100% of the measured recipient defect dimensions. |
| 110% Graft Size | Experimental | Procedure: Full-Thickness Skin Graft SizingParticipants will receive a full-thickness skin graft harvested at 110% of the measured recipient defect dimensions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Undergoing dermatologic surgery resulting in a nasal or auricular defect appropriate for full-thickness skin graft reconstruction
- Able to provide informed consent
- Willing and able to complete required study follow-up and photography
Key exclusion criteria (12 listed)
- Age younger than 18 years
- Prisoners
- Pregnant women
- Non-English-speaking individuals
- Concurrent enrollment in another ongoing interventional trial
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 |
|---|---|---|
| Full-Thickness Skin Graft SizingParticipants will undergo full-thickness skin graft reconstruction using a graft harvested at 90%, 100%, or 110% of the measured recipient defect dimensions, according to randomized treatment assignment. Graft harvest, preparation, inset, fixation, donor-site selection, and postoperative wound care will otherwise follow routine clinical practice. | Procedure or surgery | 100% Graft Size, 110% Graft Size, 90% Graft Size |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS) Scores
Time frame: 12 months
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS), version 2.0. The patient and observer scales each contain six items scored from 1-10, (patient: pain, itching, color, stiffness, thickness, irregularity/observer: vascularity, pigmentation, thickness, relief, pliability, surface area) yielding separate total scores ranging from 6 to 60. Higher scores indicate worse scar quality; lower scores indicate better scar quality. "Overall opinion ratings" are excluded from the total scores. Patient and observer total scores will be compared among the 90%, 100%, and 110% full-thickness skin graft sizing groups.
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 30 Oct 2026.
- Background: PubMed 36330586Liu J, Qu L, Song B. A comparative study of full-thickness skin grafting with and without subcutaneous fat preservation. Int Wound J. 2023 Apr;20(4):1160-1167. doi: 10.1111/iwj.13975. Epub 2022 Nov 3.
- Background: PubMed 34568495Shin J, Jang U, Baek SO, Lee JY. Full-Thickness Skin Graft according to Surrounding Relaxed Skin Tension Line Improves Scar Quality in Facial Defect Coverage: A Retrospective Comparative Study. Biomed Res Int. 2021 Sep 15;2021:7398090. doi: 10.1155/2021/7398090. eCollection 2021.
- Background: PubMed 27520711Stekelenburg CM, Simons JM, Tuinebreijer WE, van Zuijlen PP. Analyzing contraction of full thickness skin grafts in time: Choosing the donor site does matter. Burns. 2016 Nov;42(7):1471-1476. doi: 10.1016/j.burns.2016.02.001. Epub 2016 Aug 9.
- Background: PubMed 34967526Seo DH, Shin JY, Roh SG, Chang SC, Lee NH. A Comparative Assessment of Scars Resulting From Skin Grafts in Facial Defects. J Craniofac Surg. 2022 Jan-Feb 01;33(1):303-306. doi: 10.1097/SCS.0000000000007684.
- Background: PubMed 22453591Zilinsky I, Farber N, Weissman O, Israeli H, Haik J, Domniz N, Winkler E. Defying consensus: correct sizing of full-thickness skin grafts. J Drugs Dermatol. 2012 Apr;11(4):520-3.
- Background: PubMed 36755654Vathulya M, Rao S, Malik A, Sinha S, Kumar N, Kapoor A, Bahurupi Y. Is "Initial Size of the Graft the Real Culprit behind Primary Contraction of Full-Thickness Skin Graft"? - A Cross-Sectional Study. Arch Plast Surg. 2023 Feb 6;50(1):106-115. doi: 10.1055/s-0042-1756297. eCollection 2023 Jan.
- Background: PubMed 15962738Tuncali D, Yavuz N, Cigsar B, Gokrem S, Aslan G. Effect of full-thickness skin graft initial dimension on secondary wound contraction: experimental study in rats. Dermatol Surg. 2005 May;31(5):542-5. doi: 10.1111/j.1524-4725.2005.31158.
- Background: PubMed 16023927Andreassi A, Bilenchi R, Biagioli M, D'Aniello C. Classification and pathophysiology of skin grafts. Clin Dermatol. 2005 Jul-Aug;23(4):332-7. doi: 10.1016/j.clindermatol.2004.07.024.
- Individual participant dataSharing planned: No. IPD will not be routinely shared due to participant privacy and confidentiality considerations, including the use of clinical photographs.
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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.
Conway Huang, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-Thickness Skin Graft Sizing in people with Graft Healing, run by University of Alabama at Birmingham at 1 site in United States.
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 12 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 United States. 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?
Contact Conway Huang, MD ((205) 996-7546, chuang@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) Scores (time frame: 12 months). 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 NCT07896317, which also lists 8 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 30 Oct 2026.