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Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision

Primary Purpose

Pilonidal Sinus

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

sinus pilonidal excision+ PRGF

sinus pilonidal excision and standard cares

About this trial

This is an interventional supportive care trial for Pilonidal Sinus

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients among 13 and 65 years old
Possibility of observation during the follow-up period
Patients who have read and signed informed consent

Exclusion Criteria:

Abscessed pilonidal sinus
Recurrent pilonidal sinus
Patients treated with immunosuppressive drugs or anticoagulants

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

control group

PRGF group

Arm Description

sinus pilonidal excision and standard cares

sinus pilonidal excision+ PRGF

Outcomes

Primary Outcome Measures

healing time(days) of pilonidal sinus wound excision

Secondary Outcome Measures

postoperative pain

using VAS to assess postoperative pain

Full Information

NCT ID

NCT02246192

First Posted

August 13, 2014

Last Updated

March 18, 2015

Sponsor

Hospital Quiron Sagrado Corazon

1. Study Identification

Unique Protocol Identification Number

NCT02246192

Brief Title

Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision

Official Title

Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Quiron Sagrado Corazon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.

Detailed Description

prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications. this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pilonidal Sinus

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Experimental

Arm Description

sinus pilonidal excision and standard cares

Arm Title

PRGF group

Arm Type

Experimental

Arm Description

sinus pilonidal excision+ PRGF

Intervention Type

Procedure

Intervention Name(s)

sinus pilonidal excision+ PRGF

Intervention Description

open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively

Intervention Type

Procedure

Intervention Name(s)

sinus pilonidal excision and standard cares

Intervention Description

sinus pilonidal excision and postoperative standard care with povidone daily

Primary Outcome Measure Information:

Title

healing time(days) of pilonidal sinus wound excision

Time Frame

6 months

Secondary Outcome Measure Information:

Title

postoperative pain

Description

using VAS to assess postoperative pain

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

postoperative bleeding

Time Frame

1 week

Title

surgical site infection rate

Time Frame

1 month

Title

sinus recurrence rate

Time Frame

4 years

Title

quality of life

Description

this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients among 13 and 65 years old Possibility of observation during the follow-up period Patients who have read and signed informed consent Exclusion Criteria: Abscessed pilonidal sinus Recurrent pilonidal sinus Patients treated with immunosuppressive drugs or anticoagulants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Bellido Luque

Organizational Affiliation

Quirón Sagrado Corazón Hospital, Seville, Spain

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision

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