Trial · NCT07880197
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Wound Closure Time per Incision | Day of surgery (intraoperative) | Total time, in seconds, to close each study incision, measured during surgery by a research assistant with a stopwatch. Timing starts when final irrigation of the wound is complete and the closing suture is handed to the surgeon responsible for closure, and stops when the final suture is cut; the timer is paused for interruptions unrelated to wound closure. Closure time is compared between knotless barbed and conventional closure within matched incision pairs (the same procedure performed on the left and right limbs). |
| Secondary | Incidence of Surgical Site Infection | Up to 6 months after surgery (NHSN windows of 30 and 90 days) | Proportion of study incisions with a surgical site infection, classified as superficial incisional, deep incisional, or organ/space infection using the CDC National Healthcare Safety Network (NHSN) definitions. Superficial infections are counted within 30 days and deep incisional and organ/space infections within 90 days of surgery; wound infections diagnosed later, through the 6-month visit, are also recorded. |
| Secondary | Incidence of Wound Dehiscence | Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery | Proportion of study incisions with separation of the wound edges after closure, classified as superficial (skin and subcutaneous tissue) or deep (involving the fascia), with the management required recorded. |
| Secondary | Incidence of Suture Spitting and Other Wound Complications | Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery | Proportion of study incisions with suture spitting (extrusion of suture material through the skin or incision) or other wound events: hematoma, seroma, delayed wound healing, suture granuloma, or local hypersensitivity reaction. |
| Secondary | Observer-Rated Scar Appearance (Stony Brook Scar Evaluation Scale) | 4-6 weeks, 3 months, and 6 months after surgery (6 months is the principal time point) | Scar appearance of each study incision scored from standardized photographs by two independent reviewers masked to allocation. The Stony Brook Scar Evaluation Scale rates width, height, color, suture marks, and overall appearance as 0 or 1 each, for a total score from 0 (worst) to 5 (best); the mean of the two reviewers' scores is used. |
| Secondary | Patient-Reported Scar Assessment (POSAS Patient Scale) | 3 and 6 months after surgery (6 months is the principal time point) | Patient- or caregiver-reported assessment of each study incision using the patient scale of the Patient and Observer Scar Assessment Scale (POSAS). Six items (pain, itching, color, stiffness, thickness, and irregularity) are each rated from 1 (like normal skin) to 10 (worst imaginable) and summed to a total from 6 to 60; lower scores indicate a better scar. The overall opinion of the scar is rated separately from 1 to 10. |
| Secondary | Number of Device-Related Events | From surgery through 6 months after surgery | Number of intraoperative device problems (suture breakage, needle detachment, or loss of tissue hold) and postoperative device-related events (suture extrusion, suture granuloma, or hypersensitivity reaction) for each closure method. |
| Secondary | Projected Closure Time Saved per Surgical Case | Day of surgery (intraoperative) | For each participant, the within-pair differences in closure time (conventional minus knotless barbed closure) summed across all matched incision pairs, reported in minutes per case and converted to estimated operating room cost (US dollars) using published per-minute operating room costs. |
| Other | Closure Time per Centimeter of Incision | Day of surgery (intraoperative) | Closure time in seconds divided by incision length in centimeters, with length measured using a sterile ruler immediately before closure; compared between closure methods within matched incision pairs. |
| Other | Closure Time Difference by Surgeon Training Level and Procedure Type | Day of surgery (intraoperative) | Within-pair difference in closure time (seconds) analyzed according to the closing surgeon's level of training (attending surgeon, fellow, or resident) and the type of procedure. |
| Other | Suture Use and Cost per Limb | Day of surgery (intraoperative) | Number, type, and acquisition cost (US dollars) of suture packages used to close the study incisions on each limb. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07880197/registered