Pilonidal Disease of Natal CleftNCT04430413
Effect of Platelet Rich Plasma on Healing of Operated Pilonidal Sinus by Open Method
A study testing Platelet Rich Plasma in people with Pilonidal Disease of Natal Cleft, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pilonidal Disease of Natal Cleft
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age >18 years and <45 years.
- All patient who underwent sacrococcygeal pilonidal sinus operation (Open method).
Who cannot join
- Pilonidal abscess.
- Diabetic patient.
- HGB < 10 g/dl.
- Platelet count < 105/ul.
- Anticoagulant treatment.
- Wound cavity >35cc.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafr El Sheikh University Hospital
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: Assessment of the Effect of Platelet Rich Plasma on the Healing of Operated Sacrococcygeal Pilonidal Sinus by Open Method
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
Read the detailed description
Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.
Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of age. It occurs rarely after the age of 45 and children.
Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle infection. The disease results from chronic infection of hair follicles and subsequent formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge through a midline sinus follow.
Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality of life and social function. These sinuses may become infected and present as acute abscesses. Management of these abscesses is uncontroversial and revolves around incision and drainage, however, the mode of surgical management of the chronic discharging sinus is variable, contentious, and problematic.
The Principles of Surgical strategies require eradication of the sinus tract, complete healing of the overlying skin, and prevention of recurrence. Many methods are available for surgical management of PNS which is treated by wide excision. After excision, the wound may be left open to heal with granulation tissue, or may be immediate closed with a midline closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is not yet a consensus on the optimal treatment.
Excision and healing by granulation is still preferred due to the low recurrence rate of (3.4%) compering with other methods (20.6%) for midline closure and (10.3%) for off-midline closure but the healing time is lengthy and requires a prolonged time of daily dressing with a risk of infection and delayed wound healing. Therefore, the search for a treatment with minimal pain, accelerated healing time and a short span of time for returning to the normal daily activities is vastly pursued.
A recent method to promote the wound-healing process is the local administration of an autologous platelet concentrate suspended in plasma named as platelet rich plasma (PRP) which contains growth factors. Concentrated growth factors have been reported to accelerate wound healing by 30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions, maxillofacial and plastic surgeries by presenting these high amounts of growth factors and chemokines.
When platelets become activated, Seven fundamental protein growth factors that are actively secreted by platelet initiate all wound healing process, including platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) \& insulin like growth factor (ILGF 1) all participate in the acceleration of wound-healing process.
- Conditions
- Pilonidal Disease of Natal Cleft
- Being tested
- Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Disease of Natal CleftStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gohar, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430413
- Sponsor's protocol ID
- PRP injection in operated PNS
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19010110Al-Jaberi TM. Excision and simple primary closure of chronic pilonidal sinus. Eur J Surg. 2001 Feb;167(2):133-5. doi: 10.1080/110241501750070600.
PubMed 11266254McCallum 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.
PubMed 17943897Anderson 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.
PubMed 18193323Aksahin 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.
PubMed 22399039Gohar 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.
PubMed 32962673
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Platelet Rich Plasma on the Healing of Operated Sacrococcygeal Pilonidal Sinus by Open Method
- ClinicalTrials.gov ID
- NCT04430413
- Acronym / sponsor ID
- PRP injection in operated PNS
- Conditions
- Pilonidal Disease of Natal Cleft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.
Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of age. It occurs rarely after the age of 45 and children.
Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle infection. The disease results from chronic infection of hair follicles and subsequent formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge through a midline sinus follow.
Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality of life and social function. These sinuses may become infected and present as acute abscesses. Management of these abscesses is uncontroversial and revolves around incision and drainage, however, the mode of surgical management of the chronic discharging sinus is variable, contentious, and problematic.
The Principles of Surgical strategies require eradication of the sinus tract, complete healing of the overlying skin, and prevention of recurrence. Many methods are available for surgical management of PNS which is treated by wide excision. After excision, the wound may be left open to heal with granulation tissue, or may be immediate closed with a midline closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is not yet a consensus on the optimal treatment.
Excision and healing by granulation is still preferred due to the low recurrence rate of (3.4%) compering with other methods (20.6%) for midline closure and (10.3%) for off-midline closure but the healing time is lengthy and requires a prolonged time of daily dressing with a risk of infection and delayed wound healing. Therefore, the search for a treatment with minimal pain, accelerated healing time and a short span of time for returning to the normal daily activities is vastly pursued.
A recent method to promote the wound-healing process is the local administration of an autologous platelet concentrate suspended in plasma named as platelet rich plasma (PRP) which contains growth factors. Concentrated growth factors have been reported to accelerate wound healing by 30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions, maxillofacial and plastic surgeries by presenting these high amounts of growth factors and chemokines.
When platelets become activated, Seven fundamental protein growth factors that are actively secreted by platelet initiate all wound healing process, including platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) \& insulin like growth factor (ILGF 1) all participate in the acceleration of wound-healing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Platelet Rich Plasma50 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient age >18 years and <45 years.
- All patient who underwent sacrococcygeal pilonidal sinus operation (Open method).
Key exclusion criteria (6 listed)
- Pilonidal abscess.
- Diabetic patient.
- HGB < 10 g/dl.
- Platelet count < 105/ul.
- Anticoagulant treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaAutologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy. | Biological | Group B |
Primary outcome
Assessment of the wound capacity
Time frame: One Year
Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Background: PubMed 19010110Acarturk 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.
- Background: PubMed 11266254Al-Jaberi TM. Excision and simple primary closure of chronic pilonidal sinus. Eur J Surg. 2001 Feb;167(2):133-5. doi: 10.1080/110241501750070600.
- Background: PubMed 17943897McCallum 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.
- Background: PubMed 18193323Anderson 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.
- Background: PubMed 22399039Aksahin 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.
- Derived from this study: PubMed 32962673Gohar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma in people with Pilonidal Disease of Natal Cleft, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the wound capacity (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430413, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.