Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure
11. maj 2026 opdateret af: Mohamed Elsaid Hamisa, Shebin El-Kom Teaching Hospital
Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure: Results From a Randomized Controlled Trial.
Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mohamed Elsaid Hamisa
- Telefonnummer: +201092248136
- E-mail: mohamedhamisa442@gmail.com
Studiesteder
-
-
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Menoufia Governorate, Egypten, 33511
- Rekruttering
- Shebin El Koum teaching Hospital
-
Kontakt:
- Mohamed Elsaid Hamisa
- Telefonnummer: +201092248136
- E-mail: mohamedhamisa442@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cosmetic outcome measured using the Patient and Observer Scar Assessment Scale (POSAS) total score (range 6-60)
Tidsramme: Baseline
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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.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of surgical site infection (SSI) (number and percentage of patients)
Tidsramme: Baseline
|
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.
|
Baseline
|
|
Incidence of wound dehiscence (number and percentage of patients)
Tidsramme: Baseline
|
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.
|
Baseline
|
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Incidence of hematoma formation (number and percentage of patients)
Tidsramme: Baseline
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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.
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Baseline
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Patient satisfaction measured using a 5-point Likert scale (score range 1-5)
Tidsramme: Baseline
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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.
|
Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Hanna 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.
- Ramadan 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. november 2027
Datoer for studieregistrering
Først indsendt
21. april 2026
Først indsendt, der opfyldte QC-kriterier
11. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Polypropylene vs Polyglactin
Plan for individuelle deltagerdata (IPD)
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JA
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
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