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

NCT07639372 | Recruiting

• 2 other identifiers: 2026A-33326JRRA839
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultra Tension-Reducing Suture Technique

Keywords

Hypertrophic scar, surgical incision healing, Ultra Tension-Reducing Suture Technique

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure: Patient and Observer Scar Assessment Scale (POSAS) score at 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

Study Arms (2)

Arm1: Slow-absorbable PDS for ultra tension-reducing closure

EXPERIMENTAL

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.

Device: Intervention 1: 5-0 Slow-absorbable PDS suture

Arm2: Fast-absorbable Vicryl for identical ultra tension-reducing closure

ACTIVE COMPARATOR

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.

Device: Intervention 2: 5-0 Fast-absorbable Vicryl suture

Interventions

Intervention 1: 5-0 Slow-absorbable PDS suture DEVICE

Intervention 1 5-0 slow-absorbable polydioxanone (PDS) suture applied to half of the surgical incision using standardized ultra tension-reducing closure technique.

Arm1: Slow-absorbable PDS for ultra tension-reducing closure

Intervention 2: 5-0 Fast-absorbable Vicryl suture DEVICE

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.

Arm2: Fast-absorbable Vicryl for identical ultra tension-reducing closure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhenzhen Zhang: lead

Study Sites (1)

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

RECRUITING

Related Publications (14)

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  PMID: 32700009 BACKGROUND

• Moran B, Humphrey S, Seal A, Berkowitz J, Zloty D. Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial. J Am Acad Dermatol. 2020 Nov;83(5):1395-1399. doi: 10.1016/j.jaad.2020.06.016. Epub 2020 Jun 10.

  PMID: 32534080 BACKGROUND

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  PMID: 39034976 BACKGROUND

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  PMID: 39319572 BACKGROUND

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  PMID: 25357171 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhenzhen Zhang, MM

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Zhang, MM

CONTACT

+86 18153957828; 18153957828@163.com

Yonghong Qin, MD

CONTACT

+86 18919146244; 1070936165@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Department of Plastic Surgery

Model Details: This is a split-incision self-controlled single-group design. Each enrolled participant has one continuous surgical incision equally divided into two segments within the same wound. One segment is closed with slow-absorbable PDS suture, and the other segment is repaired with fast-absorbable polyglactin 910 suture under identical ultra tension-reducing suture technique. All other perioperative management is consistent across two wound segments to eliminate confounding variables. Outcome evaluators remain blinded to suture assignment during scar assessment.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)