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A Self-Controlled Clinical Study of Fast-Absorbable Versus Slow-Absorbable Sutures Applied in Ultra Tension-Reducing Suture Technique

5. juni 2026 opdateret af: Zhenzhen Zhang

Hypertrophic scar formation after wound healing remains a clinical challenge in plastic surgery. Ultra Tension-Reducing Suture Technique is currently the primary surgical option for preventing and reducing hypertrophic scarring.An ideal tension-relieving effect requires sustained support for 3 months postoperatively to align with the natural recovery cycle of skin tissue tensile strength. Studies both domestically and internationally have confirmed that slow-absorbing sutures yield better scar improvement outcomes than fast-absorbing sutures; non-absorbable sutures carry a relatively significant risk of scar hyperplasia due to Existing domestic and international evidence confirms superior scar outcomes with slow-absorbing sutures; non-absorbable sutures tend to aggravate scar hyperplasia due to obvious foreign-body responses. Other studies have shown that there are no statistically significant differences in infection rate, wound healing and scar formation between absorbable and non-absorbable sutures for cutaneous closure, Nevertheless, absorbable sutures eliminate suture removal, relieve patients' anxiety and discomfort, and lead to superior patient satisfaction. To date, no self-controlled studies have directly verified the specific effects of absorbable sutures with disparate absorption rates on postoperative scar formation during super-tension relieving suturing.

Accordingly, this study conducted a randomized, wound-self-controlled, evaluator-blinded comparative efficacy trial. Within the same surgical incision, supertension-relieving sutures were performed using both fast-absorbing and slow-absorbing sutures to compare postoperative scar morphology and outcomes. This study is the first to investigate the impact of sutures with different absorption rates on scar formation in super-tension-relieving suturing.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This single-center, evaluator-blinded, split-incision self-controlled investigator-initiated clinical trial is performed in the Department of Plastic Surgery, The Second Hospital of Lanzhou University, aiming to compare postoperative scar formation between fast-absorbable and slow-absorbable sutures under ultra tension-reducing cosmetic closure. Hypertrophic scar remains a common troublesome complication after wound repair; adequate long-term dermal support is essential to reduce scar hyperplasia. Current clinical evidence regarding scar performance of different-speed absorbable sutures under ultra tension-releasing suture technique is inconsistent, and relevant split-wound self-controlled clinical evidence is lacking.

All eligible subjects receive equal bisection of a single linear surgical incision. Segment A is repaired with 5-0 polydioxanone (PDS, slow-absorbable suture), and Segment B uses 5-0 polyglactin 910 (Vicryl Rapide, fast-absorbable suture). Subcutaneous tension fixation, dermal ultra tension-reducing backstitch and superficial 6-0 interrupted nylon skin closure are standardized identically across both wound segments; stitch spacing, cutting edge distance and surgical manipulation are unified to eliminate operative confounders. Postoperative wound dressing, dressing change timing and epidermal suture removal at 7-10 days follow uniform clinical routine.

Prespecified outpatient follow-up visits are scheduled at postoperative 1 week, 1 month and 3 months for scar measurement, standardized clinical photography and adverse event documentation. Two independent blinded assessors complete POSAS scoring for primary endpoint evaluation to avoid assessment bias. Collected adverse events include surgical site infection, wound dehiscence, hemorrhage, seroma, hematoma and suture foreign body reaction. Statistical analysis adopts intention-to-treat principle; paired t-test and McNemar's test are utilized for outcome comparison via SPSS 25.0 software.

No interim analysis or early stopping rules are set for this trial, and an independent Data Monitoring Committee is not established. All safety monitoring is undertaken by the study research team, with serious adverse events promptly reported to the institutional ethics committee. This research is supported by The Natural Science Foundation of Gansu Province (Grant No. 26JRRA839).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Gansu
      • Lanzhou, Gansu, Kina, 730030
        • Rekruttering
        • The Second Hospital of Lanzhou University
        • Kontakt:

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Incision length ≥ 5 cm;
  2. Clean, non-infected surgical wounds;
  3. Ability to provide written informed consent voluntarily;
  4. Scheduled for dermatologic surgery with intended linear wound closure;
  5. Able to complete required postoperative follow-up;
  6. No restriction on surgical site.

Exclusion Criteria:

  1. Incision length ≤ 5 cm;
  2. Infected or contaminated wounds;
  3. Cognitive impairment precluding provision of independent informed consent;
  4. Pregnant women;
  5. Any other conditions judged inappropriate for enrollment by investigators.

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: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm1: Slow-absorbable PDS for ultra tension-reducing closure
Half of each patient's incision is repaired with 5-0 slow-absorbable PDS using standardized ultra tension-reducing suture technique. All intraoperative and postoperative care follows unified clinical protocols.
Enhed: Intervention 1: 5-0 Slow-absorbable PDS suture
Intervention 1 5-0 slow-absorbable polydioxanone (PDS) suture applied to half of the surgical incision using standardized ultra tension-reducing closure technique.
Aktiv komparator: Arm2: Fast-absorbable Vicryl for identical ultra tension-reducing closure
The other half of the same incision is closed with 5-0 fast-absorbable Vicryl using identical ultra tension-reducing technique. All perioperative management is fully standardized.
Enhed: Intervention 2: 5-0 Fast-absorbable Vicryl suture
Intervention 2 5-0 fast-absorbable polyglactin 910 (Vicryl) suture applied to the remaining half of the same incision using identical ultra tension-reducing closure technique.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Outcome Measure: Patient and Observer Scar Assessment Scale (POSAS) score at 3 months postoperatively
Tidsramme: 3 months postoperatively
Scar outcomes are assessed by two independent blinded evaluators using POSAS. It includes 6 domains, each scored 1-10 (total 6-60). Lower scores indicate better scar quality.
3 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zhenzhen Zhang

Efterforskere

  • Ledende efterforsker: Zhenzhen Zhang, MM, Lanzhou University Second Hospital

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

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 (Faktiske)

1. marts 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026A-333
  • 26JRRA839 (Andet bevillings-/finansieringsnummer: The Natural Science Foundation of Gansu Province)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The study will not share individual participant data (IPD) due to ethical considerations regarding patient privacy and the small sample size of this single-center study.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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