NCT07127029

Brief Summary

This study is designed to evaluate the effect of using petrolatum to coat gut suture. This coating is commonly performed to make the suture more easy to handle; however, it was unknown if it affects the absorption rate of the suture. Two gut sutures were placed into the skin of 14 healthy volunteers and randomized between coated and uncoated with petrolatum. Participants self-reported the time to resorption. The study concluded that there was no significant effect to the application of petrolatum, and reinforced that the gut sutures are a natural product with some inherent variability to their absorption.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2016

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

August 8, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

PetrolatumAbsorbable SutureGut SutureFast-absorbing Gut SutureWound ClosureSuture Coating

Outcome Measures

Primary Outcomes (1)

  • Length of time that suture remains intact in skin following petrolatum coating compared with standard fast-absorbing gut suture.

    Length of time in hours of suture remaining in skin prior to breakdown was recorded for both uncoated and coated suture.

    Postprocedurally daily until suture is degraded (less than 2 weeks)

Study Arms (1)

6-0 Fast-Absorbing Gut Suture

EXPERIMENTAL

Two 6-0 fast-absorbing gut sutures were placed in the skin of deltoid, randomized to site A/B for the control (uncoated) and intervention (petrolatum coated) suture.

Device: Petrolatum coating of fast-absorbing gut suture

Interventions

6-0 fast absorbing gut suture was coated with sterile petrolatum and a single interrupted suture was placed into the skin of the deltoid

Also known as: petrolatum coating
6-0 Fast-Absorbing Gut Suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers within department of Dermatology
  • Able to receive care within the host facility (Dept of Defense)

You may not qualify if:

  • current or planned pregnancy
  • Allergy to lidocaine
  • Infection on the shoulder site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Susong JR, Neiner JR. Effect of petrolatum coating on fast-absorbing gut suture. J Am Acad Dermatol. 2018 Nov;79(5):952-953. doi: 10.1016/j.jaad.2018.04.041. Epub 2018 Apr 30. No abstract available.

    PMID: 29723559BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 17, 2025

Study Start

January 26, 2016

Primary Completion

October 14, 2016

Study Completion

October 14, 2016

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share