Comparison of outcomes of knotless barbed sutures and non-barbed sutures used as wound closure materials for subcuticular suturing at the nasolabial donor site in patients undergoing surgical rehabilitation for oral submucous fibrosis - A Study Protocol. (Preprint)
Bibliographic record
Abstract
<sec> <title>BACKGROUND</title> Oral submucous fibrosis (OSF) is a chronic, precancerous condition causing severe scarring and limited mouth opening, with advanced cases often requiring surgical reconstruction using nasolabial flaps. This process depends heavily on effective wound closure to prevent complications. Barbed sutures, a self-retaining type of suture, simplify closure by eliminating knots and reducing tension. A study aims to evaluate the use of barbed versus non-barbed sutures in oral surgeries, specifically focusing on how they impact complications and aesthetic outcomes, addressing the challenges posed by dynamic facial muscles in maxillofacial procedures. </sec> <sec> <title>OBJECTIVE</title> The primary objective of this study is to evaluate and compare the time required for closure of nasolabial donar site with Barbed (Knotless Suture) and Non-Barbed suture techniques in Oral submucous fibrosis. The secondary objectives include comparing the time required for closure of the nasolabial donor site, wound healing, and post-operative aesthetic outcomes between barbed (Knotless Suture) and non-barbed Vicryl sutures. </sec> <sec> <title>METHODS</title> This prospective observational study takes place at the department of oral and maxillofacial surgery, SGM cancer hospital, in collaboration with the Sharad Pawar Dental College Maharashtra, India, from April 2025 to January 2026. Patients clinically diagnosed with grade III or grade IV oral submucous fibrosis (OSMF) will undergo a series of preoperative procedures. A Pre-Anaesthetic checkup (PAC) will also be conducted to assess their fitness for surgery. Once the patients meet all inclusion criteria they will be scheduled for the surgical procedure. Group A will receive 3-0 polyglyconate barbed suture and group B will receive 3-0 poliglecaprone vicryl suture. Patients will be assessed based on wound closure timing, measurement of wound healing using “REEDA SCALE” and assessment of scar using “MANCHASTER SCAR SCALE(MSS)”.The outcome measures will be statistically analysed and appropriate tests applied to each outcome measures. The p-value <0.05 will be considered significant. </sec> <sec> <title>RESULTS</title> As of April 2025, institutional ethical clearance has been obtained, and patient recruitment is ongoing. Recruitment began after IEC approval and is ongoing, with 5 patients enrolled as of April 2025. Data collection is expected to be completed by December 2025, and results will be published in mid-2026. </sec> <sec> <title>CONCLUSIONS</title> This study is designed to compare 3-0 polyglyconate knotless barbed sutures with conventional 3-0 poliglecaprone (Vicryl) subcuticular sutures for closure of the nasolabial donor site in patients undergoing nasolabial flap reconstruction for advanced oral submucous fibrosis. By measuring subcuticular closure time (primary outcome) and early wound healing (REEDA) and scar quality (Manchester Scar Scale) at predefined intervals, the protocol will assess both efficiency and patient-centred aesthetic outcomes in a clinically relevant maxillofacial setting where dynamic facial musculature complicates closure. </sec> <sec> <title>CLINICALTRIAL</title> CTRI NO (CTRI/2025/06/089139) </sec>
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".