Polypropylene Versus Polyglactin in Upper Limb Subcuticular Skin Closure

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

Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure

Study Overview

• Status: Recruiting
• Conditions: Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin
• Intervention / Treatment: Procedure: Upper limb wounds subcuticular skin closure with Polypropylene; Procedure: Upper limb wounds subcuticular skin closure with Polyglactin

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Elsaid Hamisa; Phone Number: +201092248136; Email: mohamedhamisa442@gmail.com

Study Locations

• Egypt
  • Menoufia Governorate, Egypt, 33511
    • Recruiting
    • Shebin El Koum teaching Hospital
    • Contact: Mohamed Elsaid Hamisa; Phone Number: +201092248136; Email: mohamedhamisa442@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic outcome measured using the Patient and Observer Scar Assessment Scale (POSAS) total score (range 6-60)	Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), which includes both patient-reported and observer-reported components. Each item is scored from 1 to 10, with total scores ranging from 6 to 60, where lower scores indicate better cosmetic outcome.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site infection (SSI) (number and percentage of patients)	Surgical site infection will be assessed based on clinical criteria including the presence of purulent discharge, localized swelling, erythema, warmth, or wound dehiscence, with or without positive bacterial culture. The outcome will be reported as the number and percentage of patients who develop SSI during the follow-up period.	Baseline
Incidence of wound dehiscence (number and percentage of patients)	Wound dehiscence will be defined as partial or complete separation of the surgical wound edges after closure. The outcome will be assessed clinically during follow-up visits and reported as the number and percentage of patients who develop wound dehiscence.	Baseline
Incidence of hematoma formation (number and percentage of patients)	Hematoma formation will be defined as a localized collection of blood at the surgical site, identified clinically by swelling, discoloration, or tension, with or without the need for evacuation. The outcome will be assessed during follow-up and reported as the number and percentage of patients who develop a hematoma.	Baseline
Patient satisfaction measured using a 5-point Likert scale (score range 1-5)	Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. The outcome will be reported as a numerical score reflecting the patient's overall satisfaction with the surgical result.	Baseline

Collaborators and Investigators

• Sponsor: Shebin El-Kom Teaching Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Plastics; Polyesters; Polypropylenes; Polyglactin 910
• Other Study ID Numbers: Polypropylene vs Polyglactin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No