Application of Platelet-rich Plasma in Pilonidal Sinus Disease

NCT04697082 | Completed DMC

• 1 other identifier: U1111-1263-3749
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Pilonidal sinus disease is a common health-care problem, and surgical excision is the standard treatment modality. Controversy still exists regarding the best surgical technique for treating pilonidal disease in terms of minimizing disease recurrence and patient discomfort. In this study, the investigators compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.

Conditions

Pilonidal Sinus; Pilonidal Disease; Wound Heal; Quality of Life; Pain

Keywords

PRP; Wound healing; Pilonidal sinus; Quality of life; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Wound Healing

  Wound healing rate was evaluated as recovery time per the cavity volume (day/cc). This showed the time required for each 1 cc volume of the cavity to be filled on a daily basis. After open or minimally invasive surgery, the volume of the cavity was measured with saline solution. The cavity was filled with saline and the volume of the cavity was determined by calculating how much fluid it took. The measurements were performed on postoperative days 0, 2, 3, 4 and 21. Therefore recovery time per the cavity volume was calculated according to the differences between the measurements.

  on postoperative days 0, 2, 3, 4 and 21

Secondary Outcomes (2)

• Visual Analog Scale (VAS) score

  at 24th hour, 48th hour, 96th hour, 120th hour and 3rd week

• Short Form-36 and Nottingham Health Profile

  before the surgery and in the postoperative 3rd week

Study Arms (3)

Group A

PLACEBO COMPARATOR

The open surgical method and a moist gauze (with saline) were applied to patients in group A

Procedure: Open surgery

Group B

EXPERIMENTAL

Open surgery and then PRP application were performed on patients in group B. After the cavity was filled with PRP, the wound was covered with a dry gauze.

Procedure: Open surgery; Other: Platelet rich plasma administration

Group C

EXPERIMENTAL

PRP was applied to the patients in group C after curettage of the sinus cavity. And again the wound was covered with a dry gauze.

Procedure: Minimal invasive surgery; Other: Platelet rich plasma administration

Interventions

Open surgery PROCEDURE

Each patient entered the operating room, and after the administration of general anaesthesia, the patient was placed in the prone position. Then, the buttocks were stretched to the lateral sides using adhesive bands to remove the disease area. The sacrococcygeal region was cleaned and disinfected with 10% povidone iodine. After covering the area around the region, the sinus tract was examined by using a thin-steel cane. The length and wealth of the cavity were noted. Then, the sinus tract was removed. The depth of the cavity was noted. Then, 50 cc of 0.9% saline solution (SS) was taken into a syringe and applied to the cavity until it filled the whole space, allowing the cavity volume to be measured accurately. The measurement was performed by subtracting the remaining saline-solution volume in the syringe from the whole syringe volume, which was 50 cc.

Group A; Group B

Minimal invasive surgery PROCEDURE

In the operating room, after the patient was placed in the prone position, the region was removed by stretching the buttocks with adhesive bands and cleaning the area with 10% povidone iodine. The largest pit was excised, and hairs in the cavity were removed with forceps. Then, the whole cavity was curetted meticulously and irrigated with SS. After haemostasis, the cavity volume was measured

Group C

Platelet rich plasma administration OTHER

Platelet rich plasma (PRP) was administered by filling the whole space from the lateral side of the cavity. After the first implementation of PRP, the second one was applied at 48 hours. Until that time, the dressing was not uncovered. PRP was applied on the 3rd, 4th and 5th days postoperatively.

Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic pilonial sinus disease
• patients who had undergone abscess drainage and remained diseased after 8-10 weeks of drainage

You may not qualify if:

• patients with acute abscess
• patients with anemia
• patients that use immunosuppressive drugs
• patients with haematological malignancy
• patients with bleeding disorder
• patients with recurrent pilonida sinus disease

Sponsors & Collaborators

• Cihangir Akyol: lead

Study Sites (1)

Ankara University School of Medicine Department of General Surgery

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Boztug CY, Karaagac Akyol T, Benlice C, Koc MA, Doganay Erdogan B, Ozcebe OI, Kuzu MA, Akyol C. Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease: a randomized controlled clinical trial. BMC Surg. 2021 Oct 21;21(1):373. doi: 10.1186/s12893-021-01370-5.

  PMID: 34670534 DERIVED

MeSH Terms

Conditions

Pilonidal Sinus; Pain

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Can Y Boztug, MD

  Ankara University School of Medicine Departmernt of General Surgery

  PRINCIPAL INVESTIGATOR

• Cihangir Akyol, MD

  Ankara University School of Medicine Departmernt of General Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Proffessor

Model Details: The patients were divided into three groups randomly. A simple randomization diagram was used for randomization. The open surgical method and a moist dressing were applied to patients in group A. Open surgery and then PRP application were performed on patients in group B. PRP was applied to the patients in group C after curettage of the sinus cavity. 49 patients were included in the analysis. In this study, we compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 6, 2021
• Study Start: March 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)