Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-08558.Citation: british journal of dermatology (2022) 187, pp318¿323 https://doi.Org/10.1111/bjd.21625.
|
Title: interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial.The objective of the study is to determine whether suturing with 1-cm interval subcuticular sutures results in better cosmetic outcomes than suturing with 2-cm interval subcuticular sutures.Between 16 april 2018 and 25 september 2018, 50 patients with postoperative defects of at least 1 cm from either mohs micrographic surgery or a surgical excision with a wound closure of at least 4 cm in length and wound location on the face or neck were included in the study.There were 39 men and 11 women with a mean age of 70.2 years (range 55¿86).Following excision of the skin lesion, the wound was then closed with a single midline buried vertical mattress subcuticular pds ii polydioxanone suture (ethicon).One side of the wound received buried vertical mattress subcuticular sutures spaced 1 cm apart vs.The other side receiving sutures spaced 2 cm apart.After placement of all subcuticular sutures, both sides of the wound were sewn with a single simple running cuticular suture using 5-0 fast absorbing plain gut (ethicon).The reported complications included superficial wound dehiscence (n=3) and suture abscesses (n=17).In conclusion, we found that 1-cm suture spacing was not significantly associated with improved overall cosmetic outcome compared with 2-cm suture spacing when evaluated by blinded observers or the patients themselves.Our results support the use of either interval.
|