PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
NCT ID: NCT05474911
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
94 participants
INTERVENTIONAL
2022-09-01
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
NCT03483480
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
NCT06647290
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
NCT01889394
Pilonidal Sinus Disease: Preliminare Study
NCT03764657
A Single Center Experience in the Management of Pilonidal Disease
NCT05892198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional care
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.
Negative pressure therapy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Minimum depth of the wound 1.5 cm.
Exclusion Criteria
* 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)
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitari de Bellvitge
OTHER
Sebastiano Biondo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sebastiano Biondo
PhD, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sebastiano Biondo, MD
Role: STUDY_CHAIR
Hospital Universitari de Bellvitge
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Roldon Golet M, Siles Hinojosa A, Gonzalez Ruiz Y, Escartin Villacampa R, Goded Broto I, Bragagnini Rodriguez P. Pilonidal sinus in adolescence: is there an ideal surgical approach? Cir Pediatr. 2021 Jul 1;34(3):119-124. English, Spanish.
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.
Caliskan M, Kosmaz K, Subasi IE, Acar A, Evren I, Bas G, Atayoglu AT. Comparison of Common Surgical Procedures in Non-complicated Pilonidal Sinus Disease, a 7-Year Follow-Up Trial. World J Surg. 2020 Apr;44(4):1091-1098. doi: 10.1007/s00268-019-05331-1.
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.
Bi S, Sun K, Chen S, Gu J. Surgical procedures in the pilonidal sinus disease: a systematic review and network meta-analysis. Sci Rep. 2020 Aug 13;10(1):13720. doi: 10.1038/s41598-020-70641-7.
Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.
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, Somme 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.
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.
Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger 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.
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.
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. No abstract available.
Calisir A, Ece I. Comparison of the Keystone flap and the Limberg flap technique in the surgical treatment of pilonidal sinus disease. Updates Surg. 2021 Dec;73(6):2341-2346. doi: 10.1007/s13304-021-01153-w. Epub 2021 Aug 20.
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.
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.
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(10):CD010318. doi: 10.1002/14651858.CD010318.pub3.
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.
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.
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.
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.
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.
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.
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):zraa003. doi: 10.1093/bjsopen/zraa003.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICPS020/22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.