Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life

NCT03757572 | Terminated DMC

• 1 other identifier: Pilonidal QoL
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the application of alginate dressings with silver and high-G cellulose and the use of simple gauge dressings in patients submitted to surgical resection of pilonidal cyst. The present trial will focus on the postoperative quality of life during the secondary intention wound healing.

Conditions

Pilonidal Cyst/Fistula

Keywords

Pilonidal; Fistula; Cyst; Alginate; Gauze; Dressings; Prospective; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Wound healing time

  Postoperative required time for wound healing. Measurement unit: days

  Maximum time frame 50 days postoperatively

Secondary Outcomes (15)

• Postoperative return to everyday activities

  Maximum time frame 50 days postoperatively

• Postoperative pain level

  7, 14, 21, 28, 35, 42 and 49 days postoperatively

• Postoperative analgesics consumption

  7, 14, 21, 28, 35, 42 and 49 days postoperatively

• Overall satisfaction level

  50 days postoperatively

• Cost of the material

  Maximum time frame 50 days postoperatively

Study Arms (2)

Alginate dressings

EXPERIMENTAL

The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Alginate dressings with silver and high-G cellulose, which combine increased absorption properties, antimicrobial action and high coherence will be used. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials for latent breathing of the skin with dressing dimensions based on the wound size, will be also placed. Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.

Other: Alginate dressings

Simple gauze dressings

ACTIVE COMPARATOR

The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Wound care will be performed with the application of simple gauze dressings. Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.

Other: Simple gauze dressings

Interventions

Alginate dressings OTHER

The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Alginate dressings with silver and high-G cellulose will be applied to the wound. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials, will be also placed. During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.

Alginate dressings

Simple gauze dressings OTHER

The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Simple gauze dressings will be applied to the wound. During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.

Simple gauze dressings

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Pilonidal cyst
• Age: 18 to 80 years
• American Society of Anesthesiologists (ASA) score: I, II, III, IV
• Disease stage I,II,III and IV

You may not qualify if:

• Pilonidal abscess
• Patient age ≥ 80 years or \< 18 years
• Pilonidal abscess

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Thessaly: collaborator

Study Sites (1)

University Hospital of Larissa

Larissa, 41110, Greece

Location

Related Publications (18)

• DWIGHT RW, MALOY JK. Pilonidal sinus; experience with 449 cases. N Engl J Med. 1953 Dec 3;249(23):926-30. doi: 10.1056/NEJM195312032492303. No abstract available.

  PMID: 13111384 BACKGROUND

• BUIE LA, CURTISS RK. Pilonidal disease. Surg Clin North Am. 1952 Aug:1247-59. No abstract available.

  PMID: 14950701 BACKGROUND

• Berry DP. Pilonidal sinus disease. J Wound Care. 1992 Sep 2;1(3):29-32. doi: 10.12968/jowc.1992.1.3.29.

  PMID: 27911182 BACKGROUND

• Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.

  PMID: 7745322 BACKGROUND

• Kronborg O, Christensen K, Zimmermann-Nielsen C. Chronic pilonidal disease: a randomized trial with a complete 3-year follow-up. Br J Surg. 1985 Apr;72(4):303-4. doi: 10.1002/bjs.1800720418.

  PMID: 3886069 BACKGROUND

• Sondenaa K, Diab R, Nesvik I, Gullaksen FP, Kristiansen RM, Saebo A, Komer H. Influence of failure of primary wound healing on subsequent recurrence of pilonidal sinus. combined prospective study and randomised controlled trial. Eur J Surg. 2002;168(11):614-8. doi: 10.1080/11024150201680007.

  PMID: 12699097 BACKGROUND

• Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available.

  PMID: 4128725 BACKGROUND

• Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.

  PMID: 12654015 BACKGROUND

• Gruessner U, Clemens M, Pahlplatz PV, Sperling P, Witte J, Rosen HR; Septocoll Study Group. Improvement of perineal wound healing by local administration of gentamicin-impregnated collagen fleeces after abdominoperineal excision of rectal cancer. Am J Surg. 2001 Nov;182(5):502-9. doi: 10.1016/s0002-9610(01)00762-0.

  PMID: 11754859 BACKGROUND

• Lewis R, Whiting P, ter Riet G, O'Meara S, Glanville J. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. Health Technol Assess. 2001;5(14):1-131. doi: 10.3310/hta5140.

  PMID: 11399237 BACKGROUND

• Armstrong JH, Barcia PJ. Pilonidal sinus disease. The conservative approach. Arch Surg. 1994 Sep;129(9):914-7; discussion 917-9. doi: 10.1001/archsurg.1994.01420330028006.

  PMID: 8080372 BACKGROUND

• Clothier PR, Haywood IR. The natural history of the post anal (pilonidal) sinus. Ann R Coll Surg Engl. 1984 May;66(3):201-3.

  PMID: 6721409 BACKGROUND

• Blanco G, Giordano M, Torelli I. [Surgical treatment of pilonidal sinus with open surgical technique]. Minerva Chir. 2003 Apr;58(2):181-7. Italian.

  PMID: 12738928 BACKGROUND

• Al-Salamah SM, Hussain MI, Mirza SM. Excision with or without primary closure for pilonidal sinus disease. J Pak Med Assoc. 2007 Aug;57(8):388-91.

  PMID: 17902520 BACKGROUND

• Irkorucu O, Erdem H, Reyhan E. The best therapy for pilonidal disease: which management for which type? World J Surg. 2012 Mar;36(3):691-2. doi: 10.1007/s00268-011-1285-2. No abstract available.

  PMID: 21956594 BACKGROUND

• Anagnostopoulos F, Niakas D, Pappa E. Construct validation of the Greek SF-36 Health Survey. Qual Life Res. 2005 Oct;14(8):1959-65. doi: 10.1007/s11136-005-3866-8.

  PMID: 16155784 BACKGROUND

• Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.

  PMID: 24899053 BACKGROUND

• Deutsch CJ, Edwards DM, Myers S. Wound dressings. Br J Hosp Med (Lond). 2017 Jul 2;78(7):C103-C109. doi: 10.12968/hmed.2017.78.7.C103. No abstract available.

  PMID: 28692373 BACKGROUND

MeSH Terms

Conditions

Fistula; Cysts

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms

Study Officials

• Ioannis Mamaloudis

  Department of Surgery, University Hospital of Larissa

  PRINCIPAL INVESTIGATOR

• Konstantinos Tepetes

  Department of Surgery, University Hospital of Larissa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will exist at the level of the investigator who will record the data postoperatively. There will be no blinding at the level of the surgeon or the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: December 25, 2018
• Primary Completion: February 25, 2021
• Study Completion: April 25, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)