Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedur… (NCT04224870) | Clinical Trial Compass
CompletedNot Applicable
Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli
United States12 participantsStarted 2020-02-12
Plain-language summary
Background:
Opioids are a class of drug that are often used to manage pain after a person has surgery. Because of the current opioid crisis, researchers want to improve ways to manage pain after surgery with fewer side effects. To do this, they need to understand pain better. In this study, they want to measure chemical reactions and find genes involved in producing the pain that people feel after surgery.
Objective:
To find the pain signals starting at the site of skin incision during surgery.
Eligibility:
People age 18 and older who are having a surgery that will last for at least 4 hours.
Design:
The participant s primary surgeon will make sure he or she is eligible for surgery.
Participants will complete a generalized pain questionnaire before the day of surgery. This will give a baseline measurement.
During surgery, 4 to 6 tissue samples at the site of incision will be taken at the following time points:
when the surgery starts
at 1, 2, 4, and 6 hours
when the wound is closed (if the surgery lasts longer than 8 hours).
The samples will only be taken if they will not prevent the wound from healing properly.
For the first 2 days after surgery, participants will complete short questionnaires about their level of pain. Each will take less than 5 minutes to complete. Their answers will be protected....
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 18 years and older. Participant will be consented for a surgical procedure (primary surgical protocol) anticipated to last longer than 4 hours.
✓. Cutaneous incisional tissue sample (removal) is determined by surgeon not to compromise the incisional closure.
Exclusion criteria
✕. Participants with known skin abnormalities (dermatologic /dermatitis conditions): psoriasis, atopic dermatitis, rosacea, cancer melanomas, basal cell as well as benign lesions, tissue burns, infections, hematomas, and contusions) at the surgical site.
✕. Participants with pre-existing scar tissue at the incision site and/or a history of surgical procedures at the same site. Pre-existing scar tissue will confound the results since the baseline is different from normal non-scar tissue and therefore cannot be used as a basis for comparison.
✕. Participants with a history of radiation treatment at the incision site, when the incision site was included in the radiation field.
✕. Participants with other skin conditions that would compromise epidermal and dermal samples in the opinion of the surgeon.
✕
What they're measuring
1
Quantitative measurements
Timeframe: end of study
Trial details
NCT IDNCT04224870
SponsorNational Institutes of Health Clinical Center (CC)
. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations (within 6 months) that would limit compliance with study requirements.
✕. The pain questionnaire will be only available in English, therefore non-English speaking/reading participants are excluded from participating in the study.