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

June 5, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • The Second Hospital of Lanzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure: Patient and Observer Scar Assessment Scale (POSAS) score at 3 months postoperatively
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhenzhen Zhang

Investigators

  • Principal Investigator: Zhenzhen Zhang, MM, Lanzhou University Second Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026A-333
  • 26JRRA839 (Other Grant/Funding Number: The Natural Science Foundation of Gansu Province)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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