PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.

Wound Heal Clinical Trial

— SINUS-TPN  

Official title:

RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474911
• Other study ID #: ICPS020/22
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2022
• Source: Hospital Universitari de Bellvitge
• Contact: Ana Gálvez Saldaña
• Phone: +34 932607500
• Email: ana.galvez[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilonidal Sinus PS is a prevalent disease in young patients. There is currently no consensus on the surgical treatment of choice. Each method is associated with different advantages and disadvantages, as well as different recurrence rates. The ideal treatment should reduce morbidity, be associated with a short hospital stay (outpatient surgery), promote rapid healing, early return to work, and have a low recurrence rate. To date, no technique meets all these criteria. However, the NPT could meet them. The use of NPT in PS could decrease healing time, achieving an early return to work. In addition, it would avoid the need for daily dressings, which would mean lower hospital costs. However, the location of the wound (sacrum) and its proximity to the anal margin mean that its use cannot be generalized.

Although two retrospective series have recently reported good results with the use of NPT in PS, a prospective, randomized study is needed to compare healing time, recurrence rates, hospital costs, and assess quality of life for determine if this could be the treatment of choice.

Although NPT is commonly used in clinical practice (being useful in closing complex wounds, with devitalized tissues, burns and wounds with exposed tendons), to date there is not enough evidence to support its use after flattening the PS and it is for this reason that we conducted this study.

In this project there is a total absence of commercial interest in the proposal. No project related to the proposed one is currently being carried out.

Description:

The study population will be made up of all patients with PS admitted to the General and Digestive Surgery service of the Hospital Universitari de Bellvitge from the start of the trial until the end of recruitment, and who meet the inclusion criteria.

Once the patients belonging to the population of interest have been identified, they will propose to participate in the clinical trial, providing complete information, as well as an information sheet with the details of the study. If you agree, the informed consent document will be provided for your signature and randomization will proceed.

Bitter et al. observed in a prospective study that the use of NTP did not reduce healing time compared to conventional closure 84 days (34-349) vs 93 days (43-264); p=0.44. However, the duration of NPT application of only 2 weeks might have been too short to see an adequate effect. Also, the small sample size could have influenced the results. On the other hand, recent publications on the use of TPN in the treatment of pilonidal sinus have shown a significant reduction in healing time (28 days) with minimal complications and adequate patient satisfaction. Taking into account the scarce evidence of the studies cited, we have decided to adopt a conservative criterion, assuming a smaller difference in time to healing between the two treatments (35 days).

To calculate the sample size, the time variable has been transformed into a logarithm. Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 94 patients, 47 subjects in the control group and 47 in the experimental group, are needed to detect a difference of 0.77. A common standard deviation of 1.26 is assumed. A rate of loss to follow-up of 10% has been estimated.

Randomization 1:1 will be performed using a statistical program at the baseline visit in outpatient clinics 48 hours after surgery, after assessing the dimensions of the wound, checking whether the participant meets the inclusion/exclusion criteria and has signed the informed consent.

For the purposes of the study and in order not to influence the type of surgery performed on patients with PS, only those patients who have undergone a flattening will be included. The 1st cure will be performed 24 hours later in the area outpatient clinic and will consist of removing the dressing, washing with physiological serum and placing a dry dressing.

48 hours after surgery, patients will be evaluated in outpatient clinics at our hospital. The dressing will be removed from the wound and after washing with serum, it will be checked if the patient meets the inclusion criteria. If you meet them, you will be offered to participate in the study and once you have signed the informed consent, randomization will proceed.

The patients will be monitored in person in outpatient clinics (CEX) by two members of the research team, made up of a nurse specialized in cures and a doctor specialized in surgery.

During the follow-up visits, a conventional dressing will be performed or the negative pressure system will be changed. Symptomatology and quality of life data will be collected through validated surveys.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• All patients diagnosed with SP (recurrence or not), who have undergone surgery.

• Minimum depth of the wound 1.5 cm.

Exclusion Criteria:

• Inferior margin of the surgical wound is located less than 3 cm from the anus

• Patients under 16 years of age

• Unable to track

• Diagnosed psychiatric illness

• Patients diagnosed with hidradenitis

• Uncontrolled diabetics

• Immunocompromised (kidney or liver transplant, chronic treatment with corticosteroids, haematological disease, neoplastic disease undergoing chemotherapy)

Related Conditions & MeSH terms

• Pilonidal Sinus
• Wound Heal

Intervention

Device:
• Negative pressure therapy
The wound will be cleaned (irrigation with Physiological Serum), the cavity and the perilesional area will be dried with gauze. A skin protection spray will be applied to avoid irritation of the skin around the wound due to the adhesive of the dressing. The cavity will be filled with a sponge. When the depth of the wound is less than 1.5 cm, it will not be necessary to fill the defect. The appropriate dressing will be applied to the size of the incision, reinforcing the edges, and it will be connected to the TPN device, ensuring correct functionality.

Other:
• Conventional wound care
The wound will be cleaned with physiological serum irrigation, the cavity will be dried with gauzes and filled with a dressing made of cellulose and silver. A skin protection spray will be applied to avoid irritation of the skin around the wound due to the adhesive of the dressing.

Locations

Country	Name	City	State
Spain	Bellvitge University Hospital	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Sebastiano Biondo	Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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Berner-Hansen V, Oma E, Willaume M, Jensen KK. Prophylactic negative pressure wound therapy after open ventral hernia repair: a systematic review and meta-analysis. Hernia. 2021 Dec;25(6):1481-1490. doi: 10.1007/s10029-021-02485-7. Epub 2021 Aug 14. Review. — View Citation

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Chen L, Zhang S, Da J, Wu W, Ma F, Tang C, Li G, Zhong D, Liao B. A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer. Ann Palliat Med. 2021 Oct;10(10):10830-10839. doi: 10.21037/apm-21-2476. — View Citation

Cheung DC, Muaddi H, de Almeida JR, Finelli A, Karanicolas P. Cost-Effectiveness Analysis of Negative Pressure Wound Therapy to Prevent Surgical Site Infection After Elective Colorectal Surgery. Dis Colon Rectum. 2022 May 1;65(5):767-776. doi: 10.1097/DCR.0000000000002154. — View Citation

Frear CC, Griffin BR, Cuttle L, Kimble RM, McPhail SM. Cost-effectiveness of adjunctive negative pressure wound therapy in paediatric burn care: evidence from the SONATA in C randomised controlled trial. Sci Rep. 2021 Aug 17;11(1):16650. doi: 10.1038/s41598-021-95893-9. — View Citation

Gao J, Wang Y, Song J, Li Z, Ren J, Wang P. Negative pressure wound therapy for surgical site infections: A systematic review and meta-analysis. J Adv Nurs. 2021 Oct;77(10):3980-3990. doi: 10.1111/jan.14876. Epub 2021 Apr 27. Review. Erratum in: J Adv Nurs. 2022 Jun;78(6):1848. — View Citation

Giordano P, Schembari E, Keshishian K, Leo CA. Negative pressure-assisted endoscopic pilonidal sinus treatment. Tech Coloproctol. 2021 Jun;25(6):739-743. doi: 10.1007/s10151-021-02431-w. Epub 2021 Mar 23. — View Citation

Grabowski J, Oyetunji TA, Goldin AB, Baird R, Gosain A, Lal DR, Kawaguchi A, Downard C, Sola JE, Arthur LG, Shelton J, Diefenbach KA, Kelley-Quon LI, Williams RF, Ricca RL, Dasgupta R, St Peter SD, Sømme S, Guner YS, Jancelewicz T. The management of pilonidal disease: A systematic review. J Pediatr Surg. 2019 Nov;54(11):2210-2221. doi: 10.1016/j.jpedsurg.2019.02.055. Epub 2019 Mar 19. — View Citation

Hannan E, Harding T, Feizal H, Martin S. Negative pressure wound therapy following excision of pilonidal sinus disease: A retrospective review. Colorectal Dis. 2021 Nov;23(11):2961-2966. doi: 10.1111/codi.15890. Epub 2021 Sep 12. — View Citation

Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084. Review. — View Citation

Iesalnieks I, Ommer A, Petersen S, Doll D, Herold A. German national guideline on the management of pilonidal disease. Langenbecks Arch Surg. 2016 Aug;401(5):599-609. doi: 10.1007/s00423-016-1463-7. Epub 2016 Jun 16. Review. — View Citation

Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. — View Citation

Kim S, Kang SI. The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study). Trials. 2020 Jan 6;21(1):24. doi: 10.1186/s13063-019-3925-z. — View Citation

Kojima K, Goto M, Nagashima Y, Saito Y, Kawai M, Takebe S, Egawa A, Tanba M, Ishikawa K, Matsuoka H, Masaki T, Sunami E, Ohura N, Teruya K, Eto K, Nozawa K, Sakamoto K, Funahashi K. Effectiveness of negative pressure wound therapy for the wound of ileostomy closure: a multicenter, phase II randomized controlled trial. BMC Surg. 2021 Dec 28;21(1):442. doi: 10.1186/s12893-021-01446-2. — View Citation

Kumar M, Clay WH, Lee MJ, Brown SR, Hind D. A mapping review of sacrococcygeal pilonidal sinus disease. Tech Coloproctol. 2021 Jun;25(6):675-682. doi: 10.1007/s10151-021-02432-9. Epub 2021 Mar 16. Review. — View Citation

Liu Z, Dumville JC, Hinchliffe RJ, Cullum N, Game F, Stubbs N, Sweeting M, Peinemann F. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev. 2018 Oct 17;10:CD010318. doi: 10.1002/14651858.CD010318.pub3. — View Citation

Luedi MM, Schober P, Stauffer VK, Diekmann M, Andereggen L, Doll D. Gender-specific prevalence of pilonidal sinus disease over time: A systematic review and meta-analysis. ANZ J Surg. 2021 Jul;91(7-8):1582-1587. doi: 10.1111/ans.16990. Epub 2021 Jun 7. — View Citation

Maranna H, Lal P, Mishra A, Bains L, Sawant G, Bhatia R, Kumar P, Beg MY. Negative pressure wound therapy in grade 1 and 2 diabetic foot ulcers: A randomized controlled study. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):365-371. doi: 10.1016/j.dsx.2021.01.014. Epub 2021 Jan 23. — View Citation

McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and meta-analysis. BMJ. 2008 Apr 19;336(7649):868-71. doi: 10.1136/bmj.39517.808160.BE. Epub 2008 Apr 7. Review. — View Citation

Meyer J, Roos E, Abbassi Z, Buchs NC, Ris F, Toso C. Prophylactic Negative-pressure Wound Therapy Prevents Surgical Site Infection in Abdominal Surgery: An Updated Systematic Review and Meta-analysis of Randomized Controlled Trials and Observational Studies. Clin Infect Dis. 2021 Dec 6;73(11):e3804-e3813. doi: 10.1093/cid/ciaa1203. — View Citation

Milone M, Basso L, Manigrasso M, Pietroletti R, Bondurri A, La Torre M, Milito G, Pozzo M, Segre D, Perinotti R, Gallo G. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of pilonidal disease. Tech Coloproctol. 2021 Dec;25(12):1269-1280. doi: 10.1007/s10151-021-02487-8. Epub 2021 Jun 27. — View Citation

Payne C, Edwards D. Application of the Single Use Negative Pressure Wound Therapy Device (PICO) on a Heterogeneous Group of Surgical and Traumatic Wounds. Eplasty. 2014 Apr 28;14:e20. eCollection 2014. — View Citation

Prassas D, Rolfs TM, Schumacher FJ, Krieg A. Karydakis flap reconstruction versus Limberg flap transposition for pilonidal sinus disease: a meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2018 Aug;403(5):547-554. doi: 10.1007/s00423-018-1697-7. Epub 2018 Jul 31. — View Citation

Roldón Golet M, Siles Hinojosa A, González Ruiz Y, Escartín Villacampa R, Goded Broto I, Bragagnini Rodríguez P. Pilonidal sinus in adolescence: is there an ideal surgical approach? Cir Pediatr. 2021 Jul 1;34(3):119-124. English, Spanish. — View Citation

Saunders C, Nherera LM, Horner A, Trueman P. Single-use negative-pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis. BJS Open. 2021 Jan 8;5(1). pii: zraa003. doi: 10.1093/bjsopen/zraa003. — View Citation

Searle RJ, Myers D. A survey of caesarean section surgical site infections with PICO™ Single Use Negative Pressure Wound Therapy System in high-risk patients in England and Ireland. J Hosp Infect. 2017 Oct;97(2):122-124. doi: 10.1016/j.jhin.2017.02.023. Epub 2017 Aug 12. — View Citation

Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnüriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cicatrization	Time in days from surgery to complete epithelialization of the wound, assessed by the dressing nurse and surgeon.	1 year
Secondary	Wound size	Defined as wound volume measured in milliliters. In addition, the measurements of width, length and depth in cm will be collected.	1 year
Secondary	Postoperative pain	Evaluated with the visual analog pain scale ranging from 0 to 10, where 0 represents no pain and 10 represents intolerable pain. It will be assessed weekly	1 year
Secondary	Time of incorporation into daily activities	Time in days from surgery to incorporation into daily activities as reported by the patients in the weekly evaluation	1 year
Secondary	Patient quality of life	Evaluated by applying the SF-36 questionnaire in both groups at 15 days, 30 days, and monthly until healing. A total score will be calculated in each of the 8 sections and converted to a scale from 0 to 100, with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.	1 year
Secondary	Patient satisfaction	Reported by the patient on a scale of 0 to 10, where 0 corresponds to "totally unsatisfactory" and 10 corresponds to "totally satisfactory". The score obtained at the end of healing will be recorded. It will be done when healing is complete.	1 year
Secondary	Adverse effects related to the treatments	Reported adverse effects	1 year
Secondary	Cost effectiveness	Cost effectiveness of NPT	1 year
Secondary	Disease recurrence at follow-up	Disease recurrence will be assessed 1 year after surgery.	1 year