Effect of Platelet Rich Plasma on Healing of Operated Pilonidal Sinus by Open Method

NCT04430413 | Completed

• 1 other identifier: PRP injection in operated PNS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the healing promotion effect of platelet rich plasma in patient being operated for sacrococcygeal pilonidal sinus disease by open excision

Conditions

Pilonidal Disease of Natal Cleft

Outcome Measures

Primary Outcomes (1)

• Assessment of the wound capacity

  Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.

  One Year

Study Arms (2)

Group A

NO INTERVENTION

50 Participants who underwent a total excision of the pilonidal sinus and the wound remained open for secondary healing.

Group B

ACTIVE COMPARATOR

50 Participants who underwent the same operation with secondary healing intention but on postoperative days 4 and 12 the platelet rich plasma was injected to the surgical wound.

Biological: Platelet Rich Plasma

Interventions

Platelet Rich Plasma BIOLOGICAL

Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age \>18 years and \<45 years.
• All patient who underwent sacrococcygeal pilonidal sinus operation (Open method).

You may not qualify if:

• Pilonidal abscess.
• Diabetic patient.
• HGB \< 10 g/dl.
• Platelet count \< 105/ul.
• Anticoagulant treatment.
• Wound cavity \>35cc.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El Sheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

Related Publications (6)

• Acarturk TO, Parsak CK, Sakman G, Demircan O. Superior gluteal artery perforator flap in the reconstruction of pilonidal sinus. J Plast Reconstr Aesthet Surg. 2010 Jan;63(1):133-9. doi: 10.1016/j.bjps.2008.07.017. Epub 2008 Nov 14.

  PMID: 19010110 BACKGROUND

• Al-Jaberi TM. Excision and simple primary closure of chronic pilonidal sinus. Eur J Surg. 2001 Feb;167(2):133-5. doi: 10.1080/110241501750070600.

  PMID: 11266254 BACKGROUND

• McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006213. doi: 10.1002/14651858.CD006213.pub2.

  PMID: 17943897 BACKGROUND

• Anderson JH, Yip CO, Nagabhushan JS, Connelly SJ. Day-case Karydakis flap for pilonidal sinus. Dis Colon Rectum. 2008 Jan;51(1):134-8. doi: 10.1007/s10350-007-9150-y. Epub 2008 Jan 12.

  PMID: 18193323 BACKGROUND

• Aksahin E, Dogruyol D, Yuksel HY, Hapa O, Dogan O, Celebi L, Bicimoglu A. The comparison of the effect of corticosteroids and platelet-rich plasma (PRP) for the treatment of plantar fasciitis. Arch Orthop Trauma Surg. 2012 Jun;132(6):781-5. doi: 10.1007/s00402-012-1488-5. Epub 2012 Mar 8.

  PMID: 22399039 BACKGROUND

• Gohar MM, Ali RF, Ismail KA, Ismail TA, Nosair NA. Assessment of the effect of platelet rich plasma on the healing of operated sacrococcygeal pilonidal sinus by lay-open technique: a randomized clinical trial. BMC Surg. 2020 Sep 22;20(1):212. doi: 10.1186/s12893-020-00865-x.

  PMID: 32962673 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of General Surgery

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

EG (1)