Unilateral Cleft LipNCT04735237
Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair in Secondary Unilateral Cleft Lip Revision
A study testing Autogenous fat injection and Surgical revision with orbicularis oris muscle reconstruction. in people with Unilateral Cleft Lip, run by Cairo University.
Trial summary
Two groups of patients with repaired unilateral cleft lip deformity having mild to moderate grooving and/or scarring of the philtral column and requiring a secondary cleft lip repair. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- Autogenous fat injection and Surgical revision with orbicularis oris muscle reconstruction.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with repaired unilateral cleft lip deformity.
- Mild to moderate grooving and/or scarring of the philtral column.
- Patients who require a secondary cleft lip repair.
- Age of the patient between 4 \& 16 years
- All patients are free from any systemic disease that may affect normal tissue healing.
Who cannot join
- Patients older than 16 years old or whose caregivers declined a revisionary operation.
- Patients with any systemic disease that may affect normal healing.
- Patients with any other craniofacial malformation.
- Syndromic cleft patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair With Orbicularis Reconstruction, in Secondary Unilateral Cleft Lip Revision (A Randomized Clinical Trial)
Two groups of patients with repaired unilateral cleft lip deformity having mild to moderate grooving and/or scarring of the philtral column and requiring a secondary cleft lip repair.
- The first group will receive upper lip fat injections into the philtral column (and other areas of volume insufficiency if needed) after manual fat liposuction from the abdomen.
- The second group will receive surgical lip revision with reconstruction of the orbicularis oris muscle using inverted horizontal mattress sutures for enhancement of the philtral ridge.
Read the detailed description
Interventions:
- Intervention group: Fat injection
Harvesting fat from the donner site:
- Surgical repair is to be done under general anesthesia.
- IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
- Tumescent fluid of normal saline and epinephrine 1:500,000 is to be hand infiltrated into the donor site (abdomen).
- The lipoaspirate is to be harvested from the donor site using manual liposuction through a small incision (less than 0.5 cm). Fat is aspirated using a blunt tipped catheter on a 10-mL syringe.
- The fat is emulsified.
Injecting fat into the lip:
- The micro fat is reloaded into a 1-mL syringe and injected with a 1.5 mm blunt-tipped grafting needle.
- Small aliquots of fat are injected into the philtral column.
- Fat is to be injected in the vermilion and any other area of volume insufficiency if needed, depending on the contour of the lip.
- Comparator group: Surgical revision with orbicularis oris muscle reconstruction.
- Surgical repair is to be done under general anesthesia.
- IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
- The original scar will be marked on the skin with methylene blue.
- The operating area will be injected with 0.5% lidocaine (containing 1:200,000 epinephrine).
- The skin will be incised along the designed line with scar removal.
- The orbicularis oris muscle stump is to be dissected medially and laterally.
- In the medial segment, the dissection is restricted to within 5 mm medially to avoid crossing the center of the philtral dimple and to prevent any disruption of the normal philtral dimple. The muscle on the lateral cleft segment is to be freed from skin and mucosal by scissor dissection.
- The medial and lateral orbicularis oris muscle stumps are approximated by means of 4-0 inverted horizontal mattress sutures.
- Conditions
- Unilateral Cleft Lip
- Being tested
- Autogenous fat injection, Surgical revision with orbicularis oris muscle reconstruction.
- Keywords
- Cleft lip, Unilateral Cleft lip, Lip revision surgery, Secondary lip repair, Autogenous fat injection
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous fat injectionProcedure or surgery
Done under general anesthesia. Fat is to be harvested from the abdomen using manual liposuction. Small aliquots of fat are to be injected into the philtral column (and in the vermilion and any other area of volume insufficiency if needed).
Surgical revision with orbicularis oris muscle reconstruction.Procedure or surgery
Also called Secondary cleft lip revision surgery
Surgical repair done under general anesthesia. The original scar will be marked on the skin with methylene blue. The skin will be incised along the designed line with scar removal. The orbicularis oris muscle stump will be dissected medially and laterally and approximated by means of 4-0 inverted horizontal mattress sutures.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous fat injection | Experimental | Fat will first be harvested from the abdomen, then injected into the lip Receives: Procedure: Autogenous fat injection |
| Surgical revision with orbicularis oris muscle reconstruction | Active comparator | Not described Receives: Procedure: Surgical revision with orbicularis oris muscle reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column height using photographs and scores of a visual analogue sale (VAS).
Change in philtral column height as assessed using photographs and scores of a visual analogue scale (scale described below).
- Same height as the normal side
- Less prominent than the normal side
- Flat philtral column
- Slight groove
- Prominent groove ( lesser scores mean better outcomes and higher scores mean worse outcomes)
Measured: preoperative, immediate postoperative, after one year.
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column projection in mm using a special device clinically.
Change in philtral column projection as assessed clinically using a special device to obtain quantitative measurements of philtral column projection in mm.
Measured: preoperative, immediate postoperative, after one year.
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in height and projection of philtral column in mm using lip ultrasonography.
Change in height and projection of philtral column as assessed using lip ultrasonography to obtain quantitative measurements of philtral column height and projection in mm.
Measured: preoperative, immediate postoperative, after one year.
Secondary outcomes (2)
Efficacy of fat injection (or lip revision surgery) in scar tissue modulation measured by assessing change in the appearance of the scar using photographs and scores of a VAS preoperatively, immediately postoperative and after one year.
Change in the appearance of the scar as assessed by photographs and scores of a three point visual analogue scale (scale described below).
- Significantly better than preoperative status
- No significant changes
- Widened scar ( lesser scores mean better outcomes and higher scores mean worse outcomes)
Measured: preoperative, immediate postoperative, after one year
Satisfaction of patient after lip injection (or lip revision surgery) as assessed by scores of a patient's satisfaction survey.
Patient's satisfaction survey (range: 0-20 points).
Measured: After one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study startOct 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Unilateral Cleft LipStudies 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
- Model description
- * A randomized controlled clinical trial. * The trial will be carried out in the clinic of Oral and Maxillofacial Surgery Department- Faculty of Dentistry-Cairo University \& Pediatric Plastic Surgery Department (clinic \& operative theatre), Cairo University. * Equal randomization: participants with equal probabilities for randomization. * Parallel group study: Each group of patient receives a single treatment simultaneously.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Ishak Faris, Cairo University
- Investigators
- Hassan Abdel-Ghany, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735237
- Sponsor's protocol ID
- Omfs 3.3.8
- Status last verified
- Aug 2021
- First submitted
- 19 Jan 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogers CR, Meara JG, Mulliken JB. The philtrum in cleft lip: review of anatomy and techniques for construction. J Craniofac Surg. 2014 Jan;25(1):9-13. doi: 10.1097/SCS.0b013e3182a2dce4.
PubMed 24240763Cho BC, Baik BS. Formation of philtral column using vertical interdigitation of orbicularis oris muscle flaps in secondary cleft lip. Plast Reconstr Surg. 2000 Oct;106(5):980-6. doi: 10.1097/00006534-200010000-00003.
PubMed 11039367Kim SW, Oh M, Park JL, Oh AK, Park CG. Functional reconstruction of the philtral ridge and dimple in the repaired cleft lip. J Craniofac Surg. 2007 Nov;18(6):1343-8. doi: 10.1097/scs.0b013e31814e07de.
PubMed 17993879Fan Q, Li Y, Danning Z, Zhang B, Chen S, Wang J. "Three-unit" muscle reconstruction in secondary cleft lip repair. Cleft Palate Craniofac J. 2015 Jan;52(1):88-95. doi: 10.1597/13-048.
PubMed 24443976Li L, Xie F, Ma T, Zhang Z. Reconstruction of Philtrum Using Partial Splitting and Folding of Orbicularis Oris Muscle in Secondary Unilateral Cleft Lip. Plast Reconstr Surg. 2015 Dec;136(6):1274-1278. doi: 10.1097/PRS.0000000000001795.
PubMed 26595020Yin N, Song T, Wu J, Chen B, Ma H, Zhao Z, Wang Y, Li H, Wu D. Unilateral microform cleft lip repair: application of muscle tension line group theory. J Craniofac Surg. 2015 Mar;26(2):343-6. doi: 10.1097/SCS.0000000000001460.
PubMed 25723667Naidoo S, Butow KW. Philtrum reconstruction in unilateral cleft lip repair. Int J Oral Maxillofac Surg. 2019 Jun;48(6):716-719. doi: 10.1016/j.ijom.2018.11.003. Epub 2018 Dec 7.
PubMed 30501933Wei J, Deng N, Herrler T, Zhang Y, Li Q, Hua C, Dai C. Short term results of philtrum reconstruction with an orbicularis oris muscle flap in cleft patients. J Craniomaxillofac Surg. 2020 Jun;48(6):569-573. doi: 10.1016/j.jcms.2020.03.008. Epub 2020 Apr 7.
PubMed 32340907Ma H, Zhang N, Yin N, Guo B. Application of a Layered Muscle Flap Technique for the Reconstruction of the Cupid's Bow and Vermilion in the Repair of Secondary Cleft Lip Deformities. J Craniofac Surg. 2019 Nov-Dec;30(8):e723-e727. doi: 10.1097/SCS.0000000000005714.
PubMed 31261342Lim AA, Allam KA, Taneja R, Kawamoto HK. Constructing the philtral column in the secondary cleft lip deformity: utilizing the palmaris longus graft. Ann Plast Surg. 2013 Mar;70(3):296-300. doi: 10.1097/SAP.0b013e3182326ef3.
PubMed 23038138Wang Y, Qi Z, Wang X. Dermis reconstruction and dermis fat graft through an intraoral incision: a new method to correct the furrowed philtral column deformity in lesser-form cleft lip. Cleft Palate Craniofac J. 2014 Mar;51(2):184-8. doi: 10.1597/12-076. Epub 2013 Jan 15.
PubMed 23320841Nadjmi N, Amadori S, Van de Casteele E. Secondary Cleft Lip Reconstruction and the Use of Pedicled, Deepithelialized Scar Tissue. Plast Reconstr Surg Glob Open. 2016 Oct 25;4(10):e1061. doi: 10.1097/GOX.0000000000001061. eCollection 2016 Oct.
PubMed 27826467Diepenbrock RM, Green JM 3rd. Autologous Fat Transfer for Maxillofacial Reconstruction. Atlas Oral Maxillofac Surg Clin North Am. 2018 Mar;26(1):59-68. doi: 10.1016/j.cxom.2017.11.002. Epub 2017 Dec 8. No abstract available.
PubMed 29362072Jones CM, Mackay DR. Autologous Fat Grafting in Cleft Lip and Palate. J Craniofac Surg. 2019 May/Jun;30(3):686-691. doi: 10.1097/SCS.0000000000005205.
PubMed 31048606Zheng D, Zhou J, Yu L, Zhang Y, Wang J. Autologous Fat Transplantation to Improve Lip Contour in Secondary Cleft Lip Deformity. J Craniofac Surg. 2020 Mar/Apr;31(2):343-346. doi: 10.1097/SCS.0000000000006071.
PubMed 31856127
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair With Orbicularis Reconstruction, in Secondary Unilateral Cleft Lip Revision (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04735237
- Acronym / sponsor ID
- Omfs 3.3.8
- Conditions
- Unilateral Cleft Lip
- Keywords
- Cleft lip, Unilateral Cleft lip, Lip revision surgery, Secondary lip repair, Autogenous fat injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Feb 2021 (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.
Two groups of patients with repaired unilateral cleft lip deformity having mild to moderate grooving and/or scarring of the philtral column and requiring a secondary cleft lip repair.
- The first group will receive upper lip fat injections into the philtral column (and other areas of volume insufficiency if needed) after manual fat liposuction from the abdomen.
- The second group will receive surgical lip revision with reconstruction of the orbicularis oris muscle using inverted horizontal mattress sutures for enhancement of the philtral ridge.
Detailed description
Interventions:
- Intervention group: Fat injection
Harvesting fat from the donner site:
- Surgical repair is to be done under general anesthesia.
- IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
- Tumescent fluid of normal saline and epinephrine 1:500,000 is to be hand infiltrated into the donor site (abdomen).
- The lipoaspirate is to be harvested from the donor site using manual liposuction through a small incision (less than 0.5 cm). Fat is aspirated using a blunt tipped catheter on a 10-mL syringe.
- The fat is emulsified.
Injecting fat into the lip:
- The micro fat is reloaded into a 1-mL syringe and injected with a 1.5 mm blunt-tipped grafting needle.
- Small aliquots of fat are injected into the philtral column.
- Fat is to be injected in the vermilion and any other area of volume insufficiency if needed, depending on the contour of the lip.
- Comparator group: Surgical revision with orbicularis oris muscle reconstruction.
- Surgical repair is to be done under general anesthesia.
- IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
- The original scar will be marked on the skin with methylene blue.
- The operating area will be injected with 0.5% lidocaine (containing 1:200,000 epinephrine).
- The skin will be incised along the designed line with scar removal.
- The orbicularis oris muscle stump is to be dissected medially and laterally.
- In the medial segment, the dissection is restricted to within 5 mm medially to avoid crossing the center of the philtral dimple and to prevent any disruption of the normal philtral dimple. The muscle on the lateral cleft segment is to be freed from skin and mucosal by scissor dissection.
- The medial and lateral orbicularis oris muscle stumps are approximated by means of 4-0 inverted horizontal mattress sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- * A randomized controlled clinical trial. * The trial will be carried out in the clinic of Oral and Maxillofacial Surgery Department- Faculty of Dentistry-Cairo University \& Pediatric Plastic Surgery Department (clinic \& operative theatre), Cairo University. * Equal randomization: participants with equal probabilities for randomization. * Parallel group study: Each group of patient receives a single treatment simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Autogenous fat injection | Experimental | Procedure: Autogenous fat injectionFat will first be harvested from the abdomen, then injected into the lip |
| Surgical revision with orbicularis oris muscle reconstruction | Active comparator | Procedure: Surgical revision with orbicularis oris muscle reconstruction. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients with repaired unilateral cleft lip deformity.
- Mild to moderate grooving and/or scarring of the philtral column.
- Patients who require a secondary cleft lip repair.
- Age of the patient between 4 \& 16 years
- All patients are free from any systemic disease that may affect normal tissue healing.
Key exclusion criteria (4 listed)
- Patients older than 16 years old or whose caregivers declined a revisionary operation.
- Patients with any systemic disease that may affect normal healing.
- Patients with any other craniofacial malformation.
- Syndromic cleft patients.
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 |
|---|---|---|
| Autogenous fat injectionDone under general anesthesia. Fat is to be harvested from the abdomen using manual liposuction. Small aliquots of fat are to be injected into the philtral column (and in the vermilion and any other area of volume insufficiency if needed). | Procedure or surgery | Autogenous fat injection |
| Surgical revision with orbicularis oris muscle reconstruction.Also: Secondary cleft lip revision surgerySurgical repair done under general anesthesia. The original scar will be marked on the skin with methylene blue. The skin will be incised along the designed line with scar removal. The orbicularis oris muscle stump will be dissected medially and laterally and approximated by means of 4-0 inverted horizontal mattress sutures. | Procedure or surgery | Surgical revision with orbicularis oris muscle reconstruction |
Primary outcome
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column height using photographs and scores of a visual analogue sale (VAS).
Time frame: preoperative, immediate postoperative, after one year.
Change in philtral column height as assessed using photographs and scores of a visual analogue scale (scale described below). 1. Same height as the normal side 2. Less prominent than the normal side 3. Flat philtral column 4. Slight groove 5. Prominent groove ( lesser scores mean better outcomes and higher scores mean worse outcomes)
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column projection in mm using a special device clinically.
Time frame: preoperative, immediate postoperative, after one year.
Change in philtral column projection as assessed clinically using a special device to obtain quantitative measurements of philtral column projection in mm.
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in height and projection of philtral column in mm using lip ultrasonography.
Time frame: preoperative, immediate postoperative, after one year.
Change in height and projection of philtral column as assessed using lip ultrasonography to obtain quantitative measurements of philtral column height and projection in mm.
2 secondary outcomes
Efficacy of fat injection (or lip revision surgery) in scar tissue modulation measured by assessing change in the appearance of the scar using photographs and scores of a VAS preoperatively, immediately postoperative and after one year.
Time frame: preoperative, immediate postoperative, after one year
Satisfaction of patient after lip injection (or lip revision surgery) as assessed by scores of a patient's satisfaction survey.
Time frame: After one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 24240763Rogers CR, Meara JG, Mulliken JB. The philtrum in cleft lip: review of anatomy and techniques for construction. J Craniofac Surg. 2014 Jan;25(1):9-13. doi: 10.1097/SCS.0b013e3182a2dce4.
- Background: PubMed 11039367Cho BC, Baik BS. Formation of philtral column using vertical interdigitation of orbicularis oris muscle flaps in secondary cleft lip. Plast Reconstr Surg. 2000 Oct;106(5):980-6. doi: 10.1097/00006534-200010000-00003.
- Background: PubMed 17993879Kim SW, Oh M, Park JL, Oh AK, Park CG. Functional reconstruction of the philtral ridge and dimple in the repaired cleft lip. J Craniofac Surg. 2007 Nov;18(6):1343-8. doi: 10.1097/scs.0b013e31814e07de.
- Background: PubMed 24443976Fan Q, Li Y, Danning Z, Zhang B, Chen S, Wang J. "Three-unit" muscle reconstruction in secondary cleft lip repair. Cleft Palate Craniofac J. 2015 Jan;52(1):88-95. doi: 10.1597/13-048.
- Background: PubMed 26595020Li L, Xie F, Ma T, Zhang Z. Reconstruction of Philtrum Using Partial Splitting and Folding of Orbicularis Oris Muscle in Secondary Unilateral Cleft Lip. Plast Reconstr Surg. 2015 Dec;136(6):1274-1278. doi: 10.1097/PRS.0000000000001795.
- Background: PubMed 25723667Yin N, Song T, Wu J, Chen B, Ma H, Zhao Z, Wang Y, Li H, Wu D. Unilateral microform cleft lip repair: application of muscle tension line group theory. J Craniofac Surg. 2015 Mar;26(2):343-6. doi: 10.1097/SCS.0000000000001460.
- Background: PubMed 30501933Naidoo S, Butow KW. Philtrum reconstruction in unilateral cleft lip repair. Int J Oral Maxillofac Surg. 2019 Jun;48(6):716-719. doi: 10.1016/j.ijom.2018.11.003. Epub 2018 Dec 7.
- Background: PubMed 32340907Wei J, Deng N, Herrler T, Zhang Y, Li Q, Hua C, Dai C. Short term results of philtrum reconstruction with an orbicularis oris muscle flap in cleft patients. J Craniomaxillofac Surg. 2020 Jun;48(6):569-573. doi: 10.1016/j.jcms.2020.03.008. Epub 2020 Apr 7.
- Background: PubMed 31261342Ma H, Zhang N, Yin N, Guo B. Application of a Layered Muscle Flap Technique for the Reconstruction of the Cupid's Bow and Vermilion in the Repair of Secondary Cleft Lip Deformities. J Craniofac Surg. 2019 Nov-Dec;30(8):e723-e727. doi: 10.1097/SCS.0000000000005714.
- Background: PubMed 23038138Lim AA, Allam KA, Taneja R, Kawamoto HK. Constructing the philtral column in the secondary cleft lip deformity: utilizing the palmaris longus graft. Ann Plast Surg. 2013 Mar;70(3):296-300. doi: 10.1097/SAP.0b013e3182326ef3.
- Background: PubMed 23320841Wang Y, Qi Z, Wang X. Dermis reconstruction and dermis fat graft through an intraoral incision: a new method to correct the furrowed philtral column deformity in lesser-form cleft lip. Cleft Palate Craniofac J. 2014 Mar;51(2):184-8. doi: 10.1597/12-076. Epub 2013 Jan 15.
- Background: PubMed 27826467Nadjmi N, Amadori S, Van de Casteele E. Secondary Cleft Lip Reconstruction and the Use of Pedicled, Deepithelialized Scar Tissue. Plast Reconstr Surg Glob Open. 2016 Oct 25;4(10):e1061. doi: 10.1097/GOX.0000000000001061. eCollection 2016 Oct.
- 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.
Hassan Abdel-Ghany, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous fat injection and Surgical revision with orbicularis oris muscle reconstruction. in people with Unilateral Cleft Lip, run by Cairo University.
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 5 inclusion and 4 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 17 Aug 2021. 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 Shereen I Faris, MSc ((002)01222944297, shereen.ishak@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column height using photographs and scores of a visual analogue sale (VAS). (time frame: preoperative, immediate postoperative, after one year.). 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 NCT04735237, which also lists 21 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 17 Aug 2021; AzTrials last refreshed its copy on 26 Oct 2026.