International Journal For Multidisciplinary Research

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Post-Market Clinical Follow-up of Six Absorbable Surgical Sutures: A Prospective Multi-Center Observational Study

Author(s) Dr. Murali Mohan S, Dr. Niranjan P, Dr. Girish Rao, Krishna R Nath, Arathy, Linu Thommi
Country India
Abstract Introduction
Surgical sutures are critical for tissue approximation following surgery or injury. Absorbable sutures eliminate the need for post-operative removal and reduce patient burden. This paper reports primary clinical data from a prospective observational Post-Market Clinical Follow-up (PMCF) study examining the clinical performance and observed safety outcomes of six absorbable surgical suture products.

Aims and Objectives
To evaluate the clinical performance, safety, and acceptability of six absorbable surgical sutures in routine elective surgical use; to assess user-reported handling quality, wound closure effectiveness (absence of wound reopening at Day 7), incidence of adverse events, and overall user satisfaction.

Materials and Methods
This prospective multi-center observational PMCF study was conducted across two surgical sites in India (January 2022 – October 2022) in accordance with MDR 2017/745 ANNEX XIV Part B, MDCG 2020-7, and ISO 14155:2020. Six absorbable suture products (n = 60 per product; total = 360) manufactured by Futura Surgicare Pvt Ltd and marketed under the Dolphin Sutures brand were evaluated. Of 360 enrolled subjects, 304 (84.2%) were per-protocol; 4 (1.1%) underwent dental procedures with sutures contraindicated in dental use (PDO, PGCL25 — true protocol deviations), and 52 (14.4%) underwent neurosurgical procedures with sutures contraindicated in neurological use (PGLA910, PGLA910 Fast, PDO Barbed — true protocol deviations). PGA, PGLA910, and PGLA910 Fast are approved for dental use; PGCL25 is approved for neurosurgical use; their subjects in these settings are per-protocol. Surgeon-reported ratings (eight attributes; 1–5 Likert scale) were analysed descriptively.

Results
Mean performance scores ranged from 4.00 (PGCL25; SD 0.279; 95% CI 3.937–3.988) to 4.93 (PDO Barbed; SD 0.255; 95% CI 4.904–4.957). All products rated “Good” or “Excellent”. Packaging-removal difficulty was reported by 100% of PGA users and 50% of PGLA910 users, requiring CAPA action. No wound dehiscence or superficial infection was recorded. Four non-serious adverse events (transitory local irritation and delayed absorption) occurred exclusively in the 4 subjects who received PDO or PGCL25 sutures during dental procedures (true protocol deviations); no AEs occurred in 304 per-protocol subjects.

Conclusion
This PMCF study supports acceptable clinical performance and user-reported safety of all six absorbable sutures within their per-protocol indications. No safety concerns were identified among 304 per-protocol subjects. Packaging usability requires corrective action for PGA and PGLA910. Only 56 of 360 subjects (15.8%) constituted true protocol deviations. Dental use of PDO and PGCL25, and neurosurgical use of PGLA910, PGLA910 Fast, and PDO Barbed, represent off-label deviations; findings from these subjects should not be used to support extended indications.
Keywords Absorbable Sutures, Post-Market Clinical Follow-Up, Wound Healing, Clinical Safety
Published In Volume 8, Issue 4, July-August 2026
Published On 2026-08-07
DOI https://doi.org/10.36948/ijfmr.2026.v08i04.84474
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