Closure vs Second Intention Healing for Wounds

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Incarceration, Under 18, Pregnant women

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to heal wounds below the knee, aiming to determine which method results in better-looking scars and improved quality of life. One group will have their wounds closed with stitches (Complex Linear Closure), while the other group will allow their wounds to heal naturally without stitches (Second Intention Healing). After three months, researchers will assess the appearance of scars and participants' quality of life. Suitable candidates for this trial have a wound below the knee from surgery and are willing to return for follow-up. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future wound care treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both complex linear closure and second intention healing have distinct safety profiles. Complex linear closure uses stitches to close a wound quickly and is generally well-tolerated, though some individuals might find the stitches uncomfortable.

In contrast, second intention healing allows wounds to heal naturally without stitches. While generally safe, this method can result in longer healing times. Some studies suggest that wounds might remain open for months, increasing the risk of infection during that period.

Overall, both treatments are considered safe but present different risks and healing durations. Participants should consider these factors when deciding which method might be best for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Closure vs Second Intention Healing trial because it explores two distinct methods for healing wounds. Complex Linear Closure involves closing wounds with two layers of sutures, which may offer faster healing and reduced scarring compared to traditional methods like simple stitches or staples. On the other hand, Second Intention Healing allows wounds to heal naturally without sutures, which might be less invasive and reduce the risk of infection. By comparing these approaches, researchers hope to find out which method is more effective and beneficial for patients, potentially leading to improved wound care practices.

What evidence suggests that this trial's treatments could be effective for wound healing below the knee?

This trial will compare Complex Linear Closure with Second Intention Healing for wound treatment. Research has shown that advanced stitching techniques, such as Complex Linear Closure, can help wounds heal faster and more effectively. Specifically, studies found that 61% of patients with wounds treated this way completely healed, compared to 39% who used other methods. Evidence also suggests that these techniques can make scars less noticeable.

In contrast, Second Intention Healing, where wounds heal naturally without stitches, usually takes longer. About 81.4% of wounds heal this way, with an average healing time of 86 days. However, these wounds might not look as good once healed compared to those treated with stitches. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for skin surgery below the knee with a lesion at least 1 cm wide, can consent to treatment, and will return for follow-up. It excludes pregnant women, minors, and incarcerated individuals.

Inclusion Criteria

Willing to return for follow up visit

Able to give informed consent themselves

Patient scheduled for cutaneous surgical procedure below the knee with a lesion excision diameter of at least 1 cm.

Exclusion Criteria

Women who are currently pregnant.

Incarceration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either complex linear closure or second intention healing for cutaneous wounds below the knee

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for scar assessment and quality of life measures

3-12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Complex Linear Closure
• Factorial Assignment
• Second Intention Healing

Trial Overview

The study compares complex linear closure versus natural healing (second intention) of wounds below the knee. Participants are randomly assigned to one of two groups to see which method leads to better aesthetic outcomes and quality of life.

How Is the Trial Designed?

Group I: Second Intention Healing Experimental Treatment 1 Intervention

The study participant will not have any sutures placed.

Group II: Complex Linear Closure Experimental Treatment 1 Intervention

The study participant will receive two layers of sutures to close the wound.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6798798/

Wound Closure Outcomes Suggest Clinical Equivalency ...

Fifty-eight of the 98 wounds (59.2%) that received vLPM applications achieved complete closure with a median time to closure of 63 days and six applications.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12418884/

Cosmetic and functional outcomes of excisional surgical ...

A total of 1655 surgical wounds, of which 1518 (91.7%) healed by SIH, from 35 studies, were included in this review. The most frequent indication for SIH was a ...

3.

clinicaltrial.be

clinicaltrial.be/en/details/189326?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Aesthetic Outcome of Complex Linear Closure vs Second ...

This study aims to investigate whether complex linear closure versus second intention healing for cutaneous surgical procedures performed below ...

4.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/390637

Wound Healing Trajectories as Predictors of Effectiveness ...

Fifty-two percent of all patients achieved 100% healing by 20 weeks; 61% of patients receiving an experimental agent had total healing compared with 39% of ...

5.

link.springer.com

link.springer.com/article/10.1007/s40138-025-00324-y

Recent Technological Advances in Dermal Wound Closure ...

Recent technological advances in dermal wound closure devices can lead to improved wound closure rates, increased speed of healing, and improved scar cosmesis.

6.

clinicsinsurgery.com

clinicsinsurgery.com/open-access/a-prospective-audit-of-the-results-of-wound-closure-using-6979.pdf

a-prospective-audit-of-the-results-of-wound-closure-using- ...

In this audit, we prospectively evaluate the surgical and cosmetic outcomes following closure of abdominoplasty wounds with the V-LocTM 180 ...

7.

journals.lww.com

journals.lww.com/c-orthopaedicpractice/fulltext/2015/07000/surgical_wound_closure_in_orthopaedic_surgery_.15.aspx

Surgical wound closure in orthopaedic surgery

This method allows surgeons to quickly close wounds without the risk of needle-stick injuries associated with suturing. One study in the knee arthroplasty ...