NCT07582679

Brief Summary

Polypropylene versus Polyglactin in Upper Limb Subcuticular Skin Closure

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Nov 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 21, 2026

Last Update Submit

May 11, 2026

Conditions

Compare Cosmetic Outcomes of Subcuticular Skin Closure Using Polypropylene and Polyglactin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of surgical site infection (SSI) (number and percentage of patients)

    Baseline

  • Incidence of wound dehiscence (number and percentage of patients)

    Baseline

  • Incidence of hematoma formation (number and percentage of patients)

    Baseline

  • Patient satisfaction measured using a 5-point Likert scale (score range 1-5)

    Baseline

Interventions

Upper limb wounds subcuticular skin closure with PolypropylenePROCEDURE

Upper limb wounds subcuticular skin closure

Upper limb wounds subcuticular skin closure with PolyglactinPROCEDURE

Upper limb wounds subcuticular skin closure with Polyglactin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shebin El Koum teaching Hospital

Menoufia Governorate, 33511, Egypt

RECRUITING

Related Publications (4)

  • 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: 15253184BACKGROUND

  • 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: 38034027BACKGROUND

  • 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

    BACKGROUND

  • 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: 26413566BACKGROUND

MeSH Terms

Interventions

PolypropylenesPolyglactin 910

Intervention Hierarchy (Ancestors)

PolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePolyesters

Central Study Contacts

Mohamed Elsaid Hamisa

CONTACT

+201092248136mohamedhamisa442@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic surgery resident

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

EG(1)