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| ID | Type | Description | Link |
|---|---|---|---|
| 26JRRA839 | Other Grant/Funding Number | The Natural Science Foundation of Gansu Province |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenzhen Zhang, MM | Contact | +86 18153957828 | 18153957828@163.com | |
| Yonghong Qin, MD | Contact | +86 18919146244 | 1070936165@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenzhen Zhang, MM | Lanzhou University Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25258499 | Background | Lambrechts M, Nazari B, Dini A, O'Brien MJ, Heard WM, Savoie FH, You Z. Comparison of the cheese-wiring effects among three sutures used in rotator cuff repair. Int J Shoulder Surg. 2014 Jul;8(3):81-5. doi: 10.4103/0973-6042.140115. | |
| 39789189 | Background | Alabdulkarim A, Shilash OMB, Alanazi NF, Sawad MB, Alhusayni M, Alresheedi W, Alanazi S, Al Qurashi AA. Comparison of Incision Closure in Hand Plastic Surgery Using Non-absorbable Versus Absorbable Sutures: A Systematic Review of Randomized Controlled Trials. Aesthetic Plast Surg. 2025 Jul;49(13):3858-3865. doi: 10.1007/s00266-024-04571-4. Epub 2025 Jan 9. |
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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.
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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.
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| 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. |
|
| 36851409 | Background | Balomenos DB, Gomicronuletsomicronu PG, Galatos AD. Comparison of Absorbable and Nonabsorbable Sutures for Intradermal Skin Closure in Dogs. Vet Sci. 2023 Feb 1;10(2):105. doi: 10.3390/vetsci10020105. |
| 32700009 | Background | Erol O, Buyuklu F, Koycu A, Jafarov S, Gultekin G, Erbek SS. Comparison of Rapid Absorbable Sutures with Nonabsorbable Sutures in Closing Transcolumellar Incision in Septorhinoplasty: Short-term Outcomes. Aesthetic Plast Surg. 2020 Oct;44(5):1759-1765. doi: 10.1007/s00266-020-01864-2. Epub 2020 Jul 22. |
| 32534080 | 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. |
| 33530860 | Background | Hamstra-Wright KL, Huxel Bliven KC, Bay RC, Aydemir B. Risk Factors for Plantar Fasciitis in Physically Active Individuals: A Systematic Review and Meta-analysis. Sports Health. 2021 May-Jun;13(3):296-303. doi: 10.1177/1941738120970976. Epub 2021 Feb 3. |
| 37334139 | Background | Min P, Zhang S, Sinaki DG, Yao P, Hu F, Wang X, Zhou D, Chai J, Zhang Y. Using Zhang's supertension-relieving suture technique with slowly-absorbable barbed sutures in the management of pathological scars: a multicenter retrospective study. Burns Trauma. 2023 Jun 15;11:tkad026. doi: 10.1093/burnst/tkad026. eCollection 2023. |
| 29390170 | Background | Wade RG, Wormald JC, Figus A. Absorbable versus non-absorbable sutures for skin closure after carpal tunnel decompression surgery. Cochrane Database Syst Rev. 2018 Feb 1;2(2):CD011757. doi: 10.1002/14651858.CD011757.pub2. |
| 36232194 | Background | Kim J, Kang HJ, Kim BS, Kim YM, Kim HN, Park JY, Choi YR, Bat-Ulzii A, Cho J. Clinical Features and Treatment of Intra-Tendinous Suture Reaction Following Achilles Tendon Repair Using Nonabsorbable Suture Material: A Retrospective Case Series Study. Int J Environ Res Public Health. 2022 Oct 8;19(19):12897. doi: 10.3390/ijerph191912897. |
| 39034976 | Background | Malhotra K, Bondje S, Sklavounos A, Mortada H, Khajuria A. Absorbable versus Nonabsorbable Sutures for Facial Skin Closure: A Systematic Review and Meta-analysis of Clinical and Aesthetic Outcomes. Arch Plast Surg. 2024 Jun 19;51(4):386-396. doi: 10.1055/a-2318-1287. eCollection 2024 Jul. |
| 39019212 | Background | Maki J, Mitoma T, Ooba H, Nakato H, Mishima S, Tani K, Eto E, Yamamoto D, Yamamoto R, Kai K, Tamada T, Akamatsu K, Kawanishi K, Masuyama H. Barbed vs conventional sutures for cesarean uterine scar defects: a randomized clinical trial. Am J Obstet Gynecol MFM. 2024 Sep;6(9):101431. doi: 10.1016/j.ajogmf.2024.101431. Epub 2024 Jul 16. |
| 39319572 | Background | Yoon MK, Liou VD, Gostimir M, McCoskey MM. Foreign body suture granuloma in canthal surgery: association with suture type. Orbit. 2025 Apr;44(2):185-189. doi: 10.1080/01676830.2024.2404678. Epub 2024 Sep 25. |
| 5111290 | Background | Madden JW, Peacock EE Jr. Studies on the biology of collagen during wound healing. 3. Dynamic metabolism of scar collagen and remodeling of dermal wounds. Ann Surg. 1971 Sep;174(3):511-20. doi: 10.1097/00000658-197109000-00017. No abstract available. |
| 25357171 | Background | Wang LZ, Ding JP, Yang MY, Chen B. Forty-five cases of chest keloids treated with subcutaneous super-tension-reduction suture combined with postoperative electron-beam irradiation. Dermatol Surg. 2014 Dec;40(12):1378-84. doi: 10.1097/DSS.0000000000000163. |
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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