Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli

NCT04224870 | Completed

• 2 other identifiers: 20003120-CC-0031
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Abdominal Surgery; Thoracic Surgery; Urological Surgery

Keywords

Epidermal; Transcriptomics; Dermal; Surgery; Incision; Natural History

Outcome Measures

Primary Outcomes (1)

• Quantitative measurements

  Quantitative measurements of all expressed transcripts (by RNA-Seq) at each time point collected during surgery (initial incision, 1h, 2h, 4h, 6h, and closure). This will identify the most notable genes according to significance, expression level and fold-change.

  end of study

Secondary Outcomes (1)

• Tandem mass spectrometry (MS/MS)

  end of study

Study Arms (1)

Surgical Incision

A single cohort study, of 12 participants with a scheduled surgical procedure, of at least 4 hours, for up to six (6) timed tissue sampling at surgical incision. No investigational therapy is planned.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a tissue procurement research protocol, recruiting twelve (12) adult participants for incision tissue procurement during surgical procedures greater than four (4) hours. Potential participants are surgical candidates referred from various surgical services within the Clinical Research Center (CRC); evaluation and interest in this study will be facilitated by the primary surgeon. Once primary informed consent is obtained, the potential participant will be approached by our research team to discuss the tissue procurement study in further detail, and if interested, will be given a Read Only informed consent document to review. On preoperative admission to the CRC, research team members identified in the protocol as able to obtain consent will visit the participant and review the study. Interested participants will formally sign study consent at this time.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Andrew J Mannes, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: February 12, 2020
• Primary Completion: November 7, 2020
• Study Completion: March 15, 2021
• Last Updated: March 4, 2026

Record last verified: 2026-03-02

Locations

US (1)