Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and PolyglactinNCT07582679
Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure
A study testing Upper limb wounds subcuticular skin closure with Polypropylene and Upper limb wounds subcuticular skin closure with Polyglactin in people with Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin, run by Shebin El-Kom Teaching Hospital at 1 site in Egypt.
Trial summary
Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin
- What is being tested?
- Upper limb wounds subcuticular skin closure with Polypropylene and Upper limb wounds subcuticular skin closure with Polyglactin
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Nov 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Patients undergoing any surgical procedure involving the upper limb
- Procedures performed in either elective or emergency settings
- Wounds suitable for primary subcuticular skin closure
- Ability to provide informed consent
Who cannot join
- Heavily contaminated or infected wounds
- Patients with uncontrolled diabetes mellitus, chronic steroid use, immunosuppression or peripheral vascular disease
- Crush injuries and wounds with significant tissue loss
- Known allergy to suture material
- Delayed primary closure wounds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Shebin El Koum teaching Hospital
Menoufia Governorate, 33511
Mohamed Elsaid Hamisa, +201092248136, mohamedhamisa442@gmail.com
About this study
Official title: Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure: Results From a Randomized Controlled Trial.
Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure
Read the detailed description
Background and Rationale Although previous studies have compared absorbable and non-absorbable sutures, most did not specifically evaluate standardized scar outcomes for subcuticular closure in the upper limb. While upper limb wounds may not carry the same aesthetic priority as facial wounds, scars in this region are highly visible and can adversely affect patients' psychological well-being. Subcuticular suturing is commonly used to improve cosmetic outcomes and reduce wound complications. Both Polypropylene (non-absorbable) and Polyglactin (absorbable) are widely used materials, yet their comparative performance in subcuticular skin closure remains controversial.
Aim and Objectives
Primary objective:
- To compare cosmetic outcomes of subcuticular skin closure using Polypropylene and Polyglactin
Secondary objectives:
- To compare postoperative wound complication rates (including infection, wound dehiscence, and hematoma formation) between polypropylene and polyglactin sutures
- To assess patient-reported discomfort and satisfaction associated with each suture material
- To assess the influence of the nature of surgery (elective vs trauma) on wound healing outcomes for each suture type
- Conditions
- Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin
- Being tested
- Upper limb wounds subcuticular skin closure with Polypropylene, Upper limb wounds subcuticular skin closure with Polyglactin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb wounds subcuticular skin closure with PolypropyleneProcedure or surgery
Upper limb wounds subcuticular skin closure
Upper limb wounds subcuticular skin closure with PolyglactinProcedure or surgery
Upper limb wounds subcuticular skin closure with Polyglactin
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic outcome measured using the Patient and Observer Scar Assessment Scale (POSAS) total score (range 6-60)
Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), which includes both patient-reported and observer-reported components. Each item is scored from 1 to 10, with total scores ranging from 6 to 60, where lower scores indicate better cosmetic outcome.
Measured: Baseline
Secondary outcomes (4)
Incidence of surgical site infection (SSI) (number and percentage of patients)
Surgical site infection will be assessed based on clinical criteria including the presence of purulent discharge, localized swelling, erythema, warmth, or wound dehiscence, with or without positive bacterial culture. The outcome will be reported as the number and percentage of patients who develop SSI during the follow-up period.
Measured: Baseline
Incidence of wound dehiscence (number and percentage of patients)
Wound dehiscence will be defined as partial or complete separation of the surgical wound edges after closure. The outcome will be assessed clinically during follow-up visits and reported as the number and percentage of patients who develop wound dehiscence.
Measured: Baseline
Incidence of hematoma formation (number and percentage of patients)
Hematoma formation will be defined as a localized collection of blood at the surgical site, identified clinically by swelling, discoloration, or tension, with or without the need for evacuation. The outcome will be assessed during follow-up and reported as the number and percentage of patients who develop a hematoma.
Measured: Baseline
Patient satisfaction measured using a 5-point Likert scale (score range 1-5)
Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. The outcome will be reported as a numerical score reflecting the patient's overall satisfaction with the surgical result.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and PolyglactinStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shebin El-Kom Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaid Hamisa, Shebin El-Kom Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582679
- Sponsor's protocol ID
- Polypropylene vs Polyglactin
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184Hanna AJ, Sonnier JH, Coladonato C, Destine H, Wilson S, Ciccotti MG, Tjoumakaris FP, Freedman KB. Greater Patient Satisfaction With Use of Nonabsorbable Sutures Compared to Absorbable Sutures for Skin Closure Following Knee Arthroscopy: A Randomized Controlled Trial. Arthrosc Sports Med Rehabil. 2023 Nov 10;5(6):100814. doi: 10.1016/j.asmr.2023.100814. eCollection 2023 Dec.
PubMed 38034027Ramadan MS, Elhosseiny AS, Sabaa HA, Nassar SA. Evaluation of the effect of subcuticular skin closure with absorbable suture, polyglactin 910 (Vicryl), versus non-absorbable suture, polypropylene (Prolene), on the risk of wound infection and complications after caesarean section. QJM: An International Journal of Medicine. 2025;118(Suppl_1):hcaf224.173. doi:10.1093/qjmed/hcaf224.173
Hasdemir PS, Guvenal T, Ozcakir HT, Koyuncu FM, Dinc Horasan G, Erkan M, Oruc Koltan S. Comparison of Subcuticular Suture Materials in Cesarean Skin Closure. Surg Res Pract. 2015;2015:141203. doi: 10.1155/2015/141203. Epub 2015 Aug 27.
PubMed 26413566
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure: Results From a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07582679
- Acronym / sponsor ID
- Polypropylene vs Polyglactin
- Conditions
- Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shebin El-Kom Teaching HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 May 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.
Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure
Detailed description
Background and Rationale Although previous studies have compared absorbable and non-absorbable sutures, most did not specifically evaluate standardized scar outcomes for subcuticular closure in the upper limb. While upper limb wounds may not carry the same aesthetic priority as facial wounds, scars in this region are highly visible and can adversely affect patients' psychological well-being. Subcuticular suturing is commonly used to improve cosmetic outcomes and reduce wound complications. Both Polypropylene (non-absorbable) and Polyglactin (absorbable) are widely used materials, yet their comparative performance in subcuticular skin closure remains controversial.
Aim and Objectives
Primary objective:
- To compare cosmetic outcomes of subcuticular skin closure using Polypropylene and Polyglactin
Secondary objectives:
- To compare postoperative wound complication rates (including infection, wound dehiscence, and hematoma formation) between polypropylene and polyglactin sutures
- To assess patient-reported discomfort and satisfaction associated with each suture material
- To assess the influence of the nature of surgery (elective vs trauma) on wound healing outcomes for each suture type
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- Patients undergoing any surgical procedure involving the upper limb
- Procedures performed in either elective or emergency settings
- Wounds suitable for primary subcuticular skin closure
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Heavily contaminated or infected wounds
- Patients with uncontrolled diabetes mellitus, chronic steroid use, immunosuppression or peripheral vascular disease
- Crush injuries and wounds with significant tissue loss
- Known allergy to suture material
- Delayed primary closure wounds
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 |
|---|---|---|
| Upper limb wounds subcuticular skin closure with PolypropyleneUpper limb wounds subcuticular skin closure | Procedure or surgery | – |
| Upper limb wounds subcuticular skin closure with PolyglactinUpper limb wounds subcuticular skin closure with Polyglactin | Procedure or surgery | – |
Primary outcome
Cosmetic outcome measured using the Patient and Observer Scar Assessment Scale (POSAS) total score (range 6-60)
Time frame: Baseline
Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), which includes both patient-reported and observer-reported components. Each item is scored from 1 to 10, with total scores ranging from 6 to 60, where lower scores indicate better cosmetic outcome.
4 secondary outcomes
Incidence of surgical site infection (SSI) (number and percentage of patients)
Time frame: Baseline
Incidence of wound dehiscence (number and percentage of patients)
Time frame: Baseline
Incidence of hematoma formation (number and percentage of patients)
Time frame: Baseline
Patient satisfaction measured using a 5-point Likert scale (score range 1-5)
Time frame: Baseline
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 13 May 2026.
- Background: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Background: PubMed 38034027Hanna AJ, Sonnier JH, Coladonato C, Destine H, Wilson S, Ciccotti MG, Tjoumakaris FP, Freedman KB. Greater Patient Satisfaction With Use of Nonabsorbable Sutures Compared to Absorbable Sutures for Skin Closure Following Knee Arthroscopy: A Randomized Controlled Trial. Arthrosc Sports Med Rehabil. 2023 Nov 10;5(6):100814. doi: 10.1016/j.asmr.2023.100814. eCollection 2023 Dec.
- BackgroundRamadan MS, Elhosseiny AS, Sabaa HA, Nassar SA. Evaluation of the effect of subcuticular skin closure with absorbable suture, polyglactin 910 (Vicryl), versus non-absorbable suture, polypropylene (Prolene), on the risk of wound infection and complications after caesarean section. QJM: An International Journal of Medicine. 2025;118(Suppl_1):hcaf224.173. doi:10.1093/qjmed/hcaf224.173
- Background: PubMed 26413566Hasdemir PS, Guvenal T, Ozcakir HT, Koyuncu FM, Dinc Horasan G, Erkan M, Oruc Koltan S. Comparison of Subcuticular Suture Materials in Cesarean Skin Closure. Surg Res Pract. 2015;2015:141203. doi: 10.1155/2015/141203. Epub 2015 Aug 27.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb wounds subcuticular skin closure with Polypropylene and Upper limb wounds subcuticular skin closure with Polyglactin in people with Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin, run by Shebin El-Kom Teaching Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 13 May 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?
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 Mohamed Elsaid Hamisa (+201092248136, mohamedhamisa442@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic outcome measured using the Patient and Observer Scar Assessment Scale (POSAS) total score (range 6-60) (time frame: Baseline). 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 NCT07582679, which also lists 4 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 13 May 2026.