Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color
ConditionScar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelissa Pugliano-Mauro
About this trial
The present study assesses if dissolvable (fast gut) or non-dissolvable (polypropylene) epidermal sutures produce better cosmetic results in terms of dyspigmentation and scarring in patients of skin of color. Through a split-wound study design, patients undergoing standard elliptical excisions at least 3 cm in length will receive each suture type. Measurements of dyspigmentation and scarring will be made at 7 days (for the head and neck), 10 days (for the trunk and extremities), and 3 months for all locations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater. Benign and malignant lesions will be included, including those that have undergone Mohs micrographic surgery prior to standard linear closure. All body sites will be included.
Able to give informed consent
Able to return for 3 month follow up
Disqualifiers
High-tension closures not amenable to 5-0 simple running epidermal sutures
Known allergy to suture material
Pregnant
Trial design
Design model
Parallel
Treatments tested in this trial
5-0 Polypropylene epidermal suture
DeviceSplit-wound, intra-individual comparison - half of wound will receive 5-0 polypropylene epidermal suture and half of wound will receive 5-0 fast gut epidermal suture
5-0 Fast gut epidermal suture
DeviceSplit-wound, intra-individual comparison - half of wound will receive 5-0 polypropylene epidermal suture and half of wound will receive 5-0 fast gut epidermal suture
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: A= left/superior half of woundExperimental treatment 2 interventions
Group B: B= right/inferior half of woundExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
POSAS
Patient and Observer Scar Assessment Scale (POSAS) outcome (6-60 scale). 6 subscales (which assess scar pain, itch, color, stiffness, thickness, and irregularity) comprise the POSAS measure and each are measured 1-10. Subscales will be summed to get a total score out of 60. Higher values represent worse outcomes.
Time frame
Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities2
POSAS
Patient and Observer Scar Assessment Scale (POSAS) outcome (6-60 scale). 6 subscales (which assess scar pain, itch, color, stiffness, thickness, and irregularity) comprise the POSAS measure and each are measured 1-10. Subscales will be summed to get a total score out of 60. Higher values represent worse outcomes.
Time frame
3 months from procedure3
Skin hyperpigmentation index
1-4 scale, higher value indicates worse outcomes (greater dyspigmentation), lower values represent better outcomes
Time frame
3 months from procedureSecondary outcomes
1
Scar width
Using a ruler to measure scar width 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.
Time frame
Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities2
Scar width
Using a ruler to measure scar width 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.
Time frame
3 months from procedure3
Complications
Incidence of surgical site infection, wound dehiscence, keloids, hematomas, suture abscesses, seromas, necrosis, and suture granulomas. Greater incidence represents worse outcomes.
Time frame
Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities4
Complications
Incidence of surgical site infection, wound dehiscence, keloids, hematomas, suture abscesses, seromas, necrosis, and suture granulomas. Greater incidence represents worse outcomes.
Time frame
3 months from procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Melissa Pugliano-Mauro
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov