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

172 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Complex Linear Closure, Factorial Assignment, Second Intention Healing?

Research shows that healing by secondary intention, where wounds are left open to heal naturally, is a common and effective method for certain types of wounds, such as those that are superficial or have dehisced (opened up after being closed). This method is often used successfully in dermatologic surgeries and is supported by healthcare professionals for its simplicity and effectiveness in appropriate cases. ^{1 2 3 4 5}

Is secondary intention healing safe for humans?

Secondary intention healing is generally safe for humans, but it may lead to complications like poor cosmetic results, nasal obstruction, or alopecia (hair loss) if not used properly. Proper wound care is important to minimize these risks. ^{1 4 5 6 7}

How does the treatment 'Closure vs Second Intention Healing for Wounds' differ from other treatments?

This treatment is unique because it compares two methods: complex linear closure, which involves stitching the wound closed, and second intention healing, which allows the wound to heal naturally without stitches. Second intention healing is often used for wounds that are heavily contaminated or in areas where surgical closure might lead to complications, offering a simpler and potentially less costly option. ^{1 5 6 7 8}

What is the purpose of this trial?

The purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized comparison of secondary closure and secondary intention in patients with superficial wound dehiscence. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Primary closure vs second-intention treatment of skin punch biopsy sites: a randomized trial. [2009]

3. England pubmed.ncbi.nlm.nih.gov

Nurses' and surgeons' views and experiences of surgical wounds healing by secondary intention: A qualitative study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of patients with open surgical wounds in Slovenia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Secondary Intention Healing and Purse-String Closures. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Second-intention healing. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Role of secondary intention healing. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Healing by secondary intention of auricular defects after Mohs surgery. [2019]