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- Study Description
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Important Links and Information
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- Instructions for requestors
- Data Use Certification (DUC) Agreement
- Talking Glossary of Genetic Terms
This study collects tissue from patients undergoing long surgeries at the NIH Clinical Center. Samples from these patients are collected from the wound edge at the initial incision, as well as 1 hours, 2 hours, 4 hours, 6 hours, and surgical closure (if the case lasts ≥8 hours). These samples were subdivided in the operating room and processed for histology, RNA-Seq, and lipidomics. Patients were also evaluated for pain ratings pre-operatively and at post-operative days 1 and 2. These pain ratings included pain intensity and interference, as well as descriptors of patient pain modalities (using the McGill Questionnaire).
- Study Design:
- Collection
- Study Type:
- Cross-Sectional
- Total number of consented subjects: 12
- Subject Sample Telemetry Report (SSTR)
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- Clinical Trials
- Study Inclusion/Exclusion Criteria
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. 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.
2. Cutaneous incisional tissue sample (removal) is determined by surgeon not to compromise the incisional closure.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
1. 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.
2. 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.
3. Participants with a history of radiation treatment at the incision site, when the incision site was included in the radiation field.
4. Participants with other skin conditions that would compromise epidermal and dermal samples in the opinion of the surgeon.
5. 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.
6. The pain questionnaire will be only available in English, therefore non-English speaking/reading participants are excluded from participating in the study.
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- Study Attribution
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Study Lead
- Matthew R. Sapio. National Institutes of Health, Clinical Center, Bethesda, MD, USA.
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Principal Investigator
- Andrew J. Mannes. National Institutes of Health, Clinical Center, Bethesda, MD, USA.
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Senior Scientist
- Michael J. Iadarola. National Institutes of Health, Clinical Center, Bethesda, MD, USA.
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Postbac Fellow
- Evelyn Li. National Institutes of Health, Clinical Center, Bethesda, MD, USA.
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Sequencing Center
- NIH Intramural Sequencing Center: NISC. National Institutes of Health, Rockville, MD, USA.
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Study Lead