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Protocol Details

A single cohort study collecting interval timed incisional epidermal and dermal tissue samples during surgical procedures to profile temporal response of tissue after noxious stimuli.

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-CC-0031

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Abdominal Surgery;
Thoracic Surgery;
Urological Surgery

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

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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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andrew J. Mannes, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 2C744
10 CENTER DR
BETHESDA MD 20892
(301) 594-3427
amannes@cc.nih.gov

Tracy S. Williams, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 2C525
10 Center Drive
Bethesda, Maryland 20892
(301) 448-5366
tracy.williams@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04224870

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