Study flyers will be posted in all doc boxes to ensure all ED personnel is aware of
ongoing studies. Initial ED history and physical examination (standard procedure).
Provider identifies patient who is felt to require suture closure. Provider will contact
study staff that approved to consent patient to consent the patient for the study. After
identification of a patient who meets inclusion criteria, the patient will be screened
for exclusion criteria by the investigators using a preprinted form on the outside of the
study envelope. If the patient has an exclusion criterion, this will be noted on this
preprinted form and the form will be saved for further data analysis without any patient
identifiers, and the patient will not be enrolled in the study. If the patient does not
have exclusion criteria, the enrollment envelope will be opened and he/she will undergo
the written consent process. After written consent is complete, the randomization
envelope is opened. There will be a question asking if buried sutures will be needed as
the group of patients needing buried sutures will have their own randomized packets to
ensure a similar amount of buried suture patients are in both the Vicryl Rapide and
nonabsorbable suture closure group. The study staff will then gather the following
information regarding wound characteristics: Measure the length and width of the
laceration, laceration location, presence of contamination, and if it is simple linear.
The laceration will then be prepped for closure using whatever cleaning or anesthesia is
felt to be appropriate by the practitioner. Suture closure will then occur with either
Vicryl Rapide or nonabsorbable suture according to randomization direction in the
envelope. After laceration closure, the practitioner will also write down on this paper
the suture size and, for the nonabsorbable group, the type of suture used. The
practitioner performing suture closure will also write down whether he/she is the nurse
practitioner (NP), physician assistant (PA), emergency medicine (EM) faculty or EM
resident. Patients will be given preprinted discharge instructions appropriate to whether
Vicryl Rapide or nonabsorbable suture was used that gives information such as precautions
for infection, information about how to do the 3-month follow-up, research coordinator
contact information, and date to return for suture removal in the nonabsorbable group.
At 30 days post enrollment, the patient will receive a call from trained Institutional
review board (IRB) approved study personnel. The pre-printed scripted form will ask
questions to determine if the patient had any complications including infection,
dehiscence, and, in the absorbable suture group, whether a return visit was needed to
have the sutures removed.
At 30 days post enrollment, study personnel will also do a chart review collecting the
following elements: Patient's age, ethnicity, gender, comorbid conditions including
diabetes mellitus, renal insufficiency, liver disease, and immunodeficiency, ED vital
signs, and whether patient was admitted or treated as outpatient for the index visit. The
chart will also be reviewed examining for any revisit to the ED during those 30 days with
any of the complications listed in the previous paragraph.
At three-months post enrollment, the research coordinator will work with the patient to
arrange an appointment to take pictures of the wound. The patient will have their
follow-up visit done at the Clinical Research Center at the University of California, San
Francisco (UCSF) Fresno building. The photographs will be taken by study personnel with
instructions on how to take these. At this time, the patient would be provided with a
gift card and log book would be signed by the patient. The photographs are then prepared
for submission to the plastic surgeon who will be evaluating them. Photographs will not
have any patient identifiers other than a study number, and would be labeled with the
anatomic area. The plastic surgeon, who is a blinded study staff to the study hypothesis,
then assesses the cosmesis of the wound on a 100-mm visual analog scale (VAS).
