WoundsNCT07912632
Complex Dermal Repair for Facial Wounds and Scars
A study testing Complex dermal layer repair, surgical closure materials and local anaesthetic and adrenaline infiltration in people with Wounds and Scar Revision, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates a complex dermal layer repair technique for the treatment of facial wounds, with the objective of preventing scar widening and reducing scar visibility. The technique is used in patients with acute facial cut wounds and in patients undergoing facial scar revision. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds, Scar Revision
- What is being tested?
- Complex dermal layer repair, surgical closure materials and local anaesthetic and adrenaline infiltration
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 30 Dec 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 16-60 years.
- Patients with acute facial cut wounds.
- Patients who are candidates for facial scar revision.
Who cannot join
- Connective tissue disease.
- Refusal to participate.
- Grossly contaminated wounds.
- Wounds associated with significant skin loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Complex Dermal Layer Repair in Treatment of Facial Cut Wounds
This study evaluates a complex dermal layer repair technique for the treatment of facial wounds, with the objective of preventing scar widening and reducing scar visibility. The technique is used in patients with acute facial cut wounds and in patients undergoing facial scar revision. Scar outcomes are assessed using the Patient and Observer Scar Assessment Scale (POSAS) at six months.
Read the detailed description
The surgical technique involves wound cleansing, local anaesthesia, de-epithelialization of one wound edge over an approximately 2 mm width, preparation of the opposing deep dermal edge, and approximation of the wound's deep layers with absorbable sutures. The de-epithelialized edge is anchored beneath the dermis of the opposing edge using 6-0 PDS sutures. The superficial skin layer is closed with 6-0 polypropylene sutures, with Steri-Strips applied as supplementary support. Skin sutures are removed within five to seven days.
- Conditions
- Wounds, Scar Revision
- Being tested
- Complex dermal layer repair, surgical closure materials, local anaesthetic and adrenaline infiltration
- Keywords
- Facial wounds, Scar revision, Dermal suturing, Complex dermal layer repair, POSAS, Scar management, Facial lacerations
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex dermal layer repairProcedure or surgery
Complex dermal layer repair
surgical closure materialsDevice
Also called Skin closure
Absorbable sutures for deep-layer approximation; 6-0 PDS sutures for dermal anchoring; 6-0 polypropylene sutures for superficial skin closure; and Steri-Strips for supplementary wound support.
local anaesthetic and adrenaline infiltrationDrug
Injection of adrenaline 1:150000 solution + Lidocaine 2% by a dose suitable to the wound length (1 cc for each 1 cm)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | intervention Receives: Procedure: Complex dermal layer repair; Device: surgical closure materials; Drug: local anaesthetic and adrenaline infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar quality assessed using the Patient and Observer Scar Assessment Scale (POSAS)
The Patient and Observer Scar Assessment Scale (POSAS) is a validated clinical and research tool used to evaluate scar quality from two independent perspectives: the clinician (Observer Scale) and the patient (Patient Scale).
Structure and Scoring:
- Scoring Range: Each item is scored on a numeric scale from 1 (like normal skin) to 10 (worst scar imaginable).
- Overall Opinion: Both the observer and the patient provide a separate overall opinion score from 1 to 10.
- Total Score: Calculated by summing the individual item scores (ranging from 6 to 60 for each scale).
Measured: Six months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2021
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Hemidan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912632
- Sponsor's protocol ID
- MS-541-2021
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) collected in this study with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Complex Dermal Layer Repair in Treatment of Facial Cut Wounds
- ClinicalTrials.gov ID
- NCT07912632
- Acronym / sponsor ID
- MS-541-2021
- Conditions
- Wounds, Scar Revision
- Keywords
- Facial wounds, Scar revision, Dermal suturing, Complex dermal layer repair, POSAS, Scar management, Facial lacerations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Nov 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 evaluates a complex dermal layer repair technique for the treatment of facial wounds, with the objective of preventing scar widening and reducing scar visibility. The technique is used in patients with acute facial cut wounds and in patients undergoing facial scar revision. Scar outcomes are assessed using the Patient and Observer Scar Assessment Scale (POSAS) at six months.
Detailed description
The surgical technique involves wound cleansing, local anaesthesia, de-epithelialization of one wound edge over an approximately 2 mm width, preparation of the opposing deep dermal edge, and approximation of the wound's deep layers with absorbable sutures. The de-epithelialized edge is anchored beneath the dermis of the opposing edge using 6-0 PDS sutures. The superficial skin layer is closed with 6-0 polypropylene sutures, with Steri-Strips applied as supplementary support. Skin sutures are removed within five to seven days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Complex dermal layer repair, Device: surgical closure materials, Drug: local anaesthetic and adrenaline infiltrationintervention |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 16-60 years.
- Patients with acute facial cut wounds.
- Patients who are candidates for facial scar revision.
Key exclusion criteria (4 listed)
- Connective tissue disease.
- Refusal to participate.
- Grossly contaminated wounds.
- Wounds associated with significant skin loss.
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 |
|---|---|---|
| Complex dermal layer repairComplex dermal layer repair | Procedure or surgery | Study group |
| surgical closure materialsAlso: Skin closureAbsorbable sutures for deep-layer approximation; 6-0 PDS sutures for dermal anchoring; 6-0 polypropylene sutures for superficial skin closure; and Steri-Strips for supplementary wound support. | Device | Study group |
| local anaesthetic and adrenaline infiltrationInjection of adrenaline 1:150000 solution + Lidocaine 2% by a dose suitable to the wound length (1 cc for each 1 cm) | Drug | Study group |
Primary outcome
Scar quality assessed using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Six months after the procedure
The Patient and Observer Scar Assessment Scale (POSAS) is a validated clinical and research tool used to evaluate scar quality from two independent perspectives: the clinician (Observer Scale) and the patient (Patient Scale). Structure and Scoring: * Scoring Range: Each item is scored on a numeric scale from 1 (like normal skin) to 10 (worst scar imaginable). * Overall Opinion: Both the observer and the patient provide a separate overall opinion score from 1 to 10. * Total Score: Calculated by summing the individual item scores (ranging from 6 to 60 for each scale).
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 3 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) collected in this study with other researchers.
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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.
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 Complex dermal layer repair, surgical closure materials and local anaesthetic and adrenaline infiltration in people with Wounds and Scar Revision, 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 3 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: finished, as of the sponsor's last update on 3 Nov 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 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. 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?
Scar quality assessed using the Patient and Observer Scar Assessment Scale (POSAS) (time frame: Six months after the procedure). 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 3 Nov 2026.