Perianal AbscessNCT07155356
Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Absces
A study testing Red light exposure and Red-blue light exposure in people with Perianal Abscess, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial summary
This study aims to investigate whether specialized red-blue light irradiation facilitates faster postoperative recovery and reduces complication rates in patients following perianal abscess surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perianal Abscess
- What is being tested?
- Red light exposure and Red-blue light exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years;
- Clinical diagnosis of perianal abscess；
- Procedure: Radical resection with incision and drainage.
Who cannot join
- Concurrent anorectal disorders (hemorrhoids, anal fissure) or malignancies/infectious diseases；
- History of psychiatric disorders；
- Analgesic use within 7 days preoperatively；
- Coagulopathy or cardiac/hepatic dysfunction；
- Pregnancy or lactation；
- Contraindications to phototherapy；
- IBD-related perianal abscess.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Abscess: a Single-center Prospective Open-label Randomized Clinical Trial
This study aims to investigate whether specialized red-blue light irradiation facilitates faster postoperative recovery and reduces complication rates in patients following perianal abscess surgery. A total of 222 eligible patients were randomly allocated equally into three groups (74 per group):①Routine Care Group: Standard wound care including cleansing and dressing changes；②Red Light Therapy Group: Routine care plus red light phototherapy；③Combined Red-Blue Light Therapy Group: Routine care plus concurrent red and blue light phototherapy.Wound healing time and incidence of complications were compared to assess postoperative recovery across interventions. The primary hypothesis posits that adjunctive phototherapy-particularly combined red-blue light irradiation-will significantly enhance wound healing, reduce edema and pain, and decrease complication rates (e.g.bleeding, urinary retention) compared to routine care alone.
- Conditions
- Perianal Abscess
- Being tested
- Red light exposure, Red-blue light exposure
- Keywords
- perianal abscess, red light phototherapy, red and blue light phototherapy, wound healing
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red light exposureDevice
Patients in the red light group received red light therapy concurrently with standard care.
Red-blue light exposureDevice
Patients in the red and blue light group received combined red and blue light therapy concurrently with standard care。
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Routine care of patients after surgery for perianal abscesses. |
| Red Ligh Group | Experimental | Postoperative care of patients with perianal abscesses using routine plus red light irradiation. Receives: Device: Red light exposure |
| Combined Red-Blue Light Group | Experimental | Use of routine plus red and blue light in postoperative care of patients with perianal abscesses. Receives: Device: Red-blue light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Defined as 100% re-epithelialization assessed by blinded evaluator.
Measured: Measurements were taken over a time frame of 24 hours postoperatively to complete epithelialisation.
Secondary outcomes (5)
Postoperative pain intensity
Assessed at rest and during defecation.Numerical Rating Scale will be used,patients are asked to choose a whole number (integer) from 0 to 10 that best describes their pain.0 usually means "no pain."10 means "the worst pain imaginable."
Measured: Baseline, Day 1, 3, 5, 7, and Day 14±2
Peripheral tissue edema（Grade 0-3）
- Grade 0 (None): No edema.
- Grade 1 (Mild): Mild edema with slight swelling around the incision; skin folds remain clearly visible.
- Grade 2 (Moderate): Moderate edema with pronounced swelling around the incision; skin folds are indistinct.
- Grade 3 (Severe): Severe edema with marked swelling around the incision; skin folds are obliterated.
Measured: Day 1, 3, 5, 7, and Day 14±2
Assessment of Granulation Tissue in Wound Bed
- Grade 0 (Absent): No granulation tissue present.
- Grade 1 (Poor): Minimal, pale, and friable granulation tissue with easy bleeding.
- Grade 2 (Fair): Moderate amount of granulation tissue; pinkish-red in color but remains somewhat friable.
- Grade 3 (Good): Healthy, abundant granulation tissue filling the wound bed; beefy red in color and firm to the touch, with minimal bleeding.
Measured: Day 1, 3, 5, 7, and Day 14±2
Length of hospital stay
Measured in hours with standardized discharge criteria.
Measured: From surgery end to discharge (up to 7 days)
Complication incidence
Measurements include the incidence of postoperative bleeding, urinary retention, etc.
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion14 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Putian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155356
- Sponsor's protocol ID
- AHPutianU-012
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Abscess: a Single-center Prospective Open-label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07155356
- Acronym / sponsor ID
- AHPutianU-012
- Conditions
- Perianal Abscess
- Keywords
- perianal abscess, red light phototherapy, red and blue light phototherapy, wound healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether specialized red-blue light irradiation facilitates faster postoperative recovery and reduces complication rates in patients following perianal abscess surgery. A total of 222 eligible patients were randomly allocated equally into three groups (74 per group):①Routine Care Group: Standard wound care including cleansing and dressing changes；②Red Light Therapy Group: Routine care plus red light phototherapy；③Combined Red-Blue Light Therapy Group: Routine care plus concurrent red and blue light phototherapy.Wound healing time and incidence of complications were compared to assess postoperative recovery across interventions. The primary hypothesis posits that adjunctive phototherapy-particularly combined red-blue light irradiation-will significantly enhance wound healing, reduce edema and pain, and decrease complication rates (e.g.bleeding, urinary retention) compared to routine care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Routine care of patients after surgery for perianal abscesses. |
| Red Ligh Group | Experimental | Device: Red light exposurePostoperative care of patients with perianal abscesses using routine plus red light irradiation. |
| Combined Red-Blue Light Group | Experimental | Device: Red-blue light exposureUse of routine plus red and blue light in postoperative care of patients with perianal abscesses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 75 years;
- Clinical diagnosis of perianal abscess；
- Procedure: Radical resection with incision and drainage.
Key exclusion criteria (7 listed)
- Concurrent anorectal disorders (hemorrhoids, anal fissure) or malignancies/infectious diseases；
- History of psychiatric disorders；
- Analgesic use within 7 days preoperatively；
- Coagulopathy or cardiac/hepatic dysfunction；
- Pregnancy or lactation；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red light exposurePatients in the red light group received red light therapy concurrently with standard care. | Device | Red Ligh Group |
| Red-blue light exposurePatients in the red and blue light group received combined red and blue light therapy concurrently with standard care。 | Device | Combined Red-Blue Light Group |
Primary outcome
Wound healing time
Time frame: Measurements were taken over a time frame of 24 hours postoperatively to complete epithelialisation.
Defined as 100% re-epithelialization assessed by blinded evaluator.
5 secondary outcomes
Postoperative pain intensity
Time frame: Baseline, Day 1, 3, 5, 7, and Day 14±2
Peripheral tissue edema（Grade 0-3）
Time frame: Day 1, 3, 5, 7, and Day 14±2
Assessment of Granulation Tissue in Wound Bed
Time frame: Day 1, 3, 5, 7, and Day 14±2
Length of hospital stay
Time frame: From surgery end to discharge (up to 7 days)
Complication incidence
Time frame: Within 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red light exposure and Red-blue light exposure in people with Perianal Abscess, run by The Affiliated Hospital of Putian University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenxing C Jian (+8613959538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: Measurements were taken over a time frame of 24 hours postoperatively to complete epithelialisation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.