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Recruiting NCT07582679

Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure

No phase Interventional Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper limb wounds subcuticular skin closure with Polypropylene, Upper limb wounds subcuticular skin closure with Polyglactin.
Who it may be relevant to
Registry conditions: Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure: Results From a Randomized Controlled Trial.

Overview

Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure

Detailed description

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

Interventions

  • Procedure Upper limb wounds subcuticular skin closure with Polypropylene
    Upper limb wounds subcuticular skin closure
  • Procedure Upper limb wounds subcuticular skin closure with Polyglactin
    Upper limb wounds subcuticular skin closure with Polyglactin

Primary outcome measures

  • Cosmetic outcome measured using the Patient and Observer Scar Assessment Scale (POSAS) total score (range 6-60) [Time frame: Baseline]
Secondary outcome measures (4)
  • Incidence of surgical site infection (SSI) (number and percentage of patients) [Time frame: Baseline]
  • Incidence of wound dehiscence (number and percentage of patients) [Time frame: Baseline]
  • Incidence of hematoma formation (number and percentage of patients) [Time frame: Baseline]
  • Patient satisfaction measured using a 5-point Likert scale (score range 1-5) [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Shebin El Koum teaching Hospital — Menoufia Governorate

Publications

  • 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. PMID 15253184
  • 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. PMID 38034027
  • 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. PMID 26413566

Identifiers

NCT: NCT07582679 · Polypropylene vs Polyglactin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗