Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606004
Status:
COMPLETED
Last Update Posted:
2021-06-01
First Post:
2020-10-21
Brief Title:
Perianal Maceration in Pediatric Ostomy Closure Patients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Perianal Maceration in Pediatric Ostomy Closure Patients
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study will explore whether preoperative application of stool from the stoma bag to the perianal area will prevent decrease postoperative perianal maceration in pediatric ostomy closure patients It will also explore the overall safety and feasibility of this pilot study for larger randomized control trials There will be a control group and an intervention group The intervention group will apply stool from the stoma bag approximately 4 weeks prior to ostomy closure and fill out a compliance log and upload pictures weekly to the MyCHP My Childrens Hospital portal A validated diaper dermatitis score will be utilized in this study
Detailed Description:
After consent participants will be assigned to either a treatment group or control group using a 2-group comparative pilot design For this pilot study to ensure adequate balance subjects will be assigned using every other technique After consent is obtained a one-time pH stool sample will be collected either at the outpatient visit or at the inpatients bedside
Pre-Operatively about 4 weeks prior to ostomy closure
Intervention Group
The parent or the inpatient healthcare provider if patient is hospitalized at any point within the 4 weeks prior to ostomy closure will follow standard of care for skin care pre-operatively which is either no application of barrier cream or an application of an over the counter skin barrier such as Aquaphor Desitin or Vitamin AD if the patient is experiencing skin redness from urine incontinence In addition to standard of care they will apply stool from the stoma bag 4 weeks prior twice daily for 10 minutes at a time However with the stool application no barrier cream will be applied to the skin in order for the stool to achieve penetrance to the skin After 10 minutes of application the caregiver or inpatient healthcare provider will remove the entire thin layer of stool gently without excessive friction just enough to remove the stool a dabbing motion is preferred Parents will be asked to upload images of their childs diaper area at least once weekly onto the MyCHP Portal if their child is not inpatient in order to monitor their skin for breakdown from and while performing the intervention If at any time redness occurs the parent will be asked to upload an additional picture to the MyCHP Patient Portal for investigatorclinician review or for visual inspection if inpatient and corresponding measurement of perianal skin breakdown Upon visual inspection or image inspection the co-investigator clinician will provide review corresponding measurement with a validated diaper dermatitis scale and provide appropriate clinical guidance
Compliance and Assessment A preoperative compliance log will be used with every stool application by the parent at home or healthcare provider This log will ask who applied the stool how long stool was on the skin description of stool skin description what brand of diapers and wipes were used diet information etc They will notify the researchers if there are worsening skin concerns at home Weekly and as needed images of buttocks areas will be uploaded into the CHP Patient Portal for clinicalresearch review by the parent or weekly visual inspections as needed assessments by the principal investigator or co-investigators for hospitalized patients pre-operatively On day of closure there will be a one time assessment to get a baseline assessment of skin prior to surgery Compliance logs will also be turned in at this time
Control Group
Skin care inpatient and outpatient
Will follow standard of care for skin care pre-operatively They will not be applying ostomy stool output to the skin but can apply an over the counter skin barrier such as Aquaphor Desitin or Vitamin AD if the patient is experiencing skin redness from urine incontinence One-time assessment on day of closure to ensure no application of stool to buttocks area was conducted during pre-operative period and to get a baseline assessment
------ Post Operatively Post op day 1 - 1st post-operative appt approximately 1-month Intervention Group and Control Group
Standard of care skin creams including 3M no-sting immediately post op once begin stooling- stoma powder 3M no-sting Critic-aid thick barrier paste will be applied to the skin The parents andor health care providers will use home-made wipes water moistened gauze to clean the skin Healthcare providers andor parents will provide q2h diaper checks If there is worsening of the skin condition or concerns the healthcare provider will notify the enterostomal nurse and place a new skin care consult Additional interventions suggested by the enterostomal nurse may include BIDtwice daily Aveeno soaks BID Domeboro soaks or blow by 02 to the buttocks
With each diaper change the caregiver andor the nurse will assess the childs diaper area
Twice weekly and as needed images of buttocks areas will be uploaded onto the CHP Childrens Hospital of Pittsburgh Patient Portal for both groups once outpatient The investigators will provide review and corresponding measurement with a validated diaper dermatitis scale
Weekly and as needed visual inspections of buttocks area for clinicalresearch review when still inpatient
At postoperative visit
Return of preoperative log if previously forgot The parent will fill out a questionnaire at this time There will be one more assessment of their skin at this appointment
Electronic Medical Record EMR Review An electronic medical record review will be performed to collect information necessary for this study including demographic data age gender race gestational age initial diagnosis comorbidities type of ostomy duration of ostomy reason for stoma closure heightweight percentiles at birth at closure formula vs breast milk diet at time of closure diet information inpatient vs outpatient intervention vs control length of stay medication use antibiotics cholestyramine Imodium Metamucil etc post-operative complications skin assessments any additional skin care interventions aveeno soaks domeboro soaks blow by 02 nystatin etc labs length of stay previous ostomy complicationsrevisionssurgeries and if discharged home prior to closureetc
Compliance log Compliance logs will be reviewed for the following If they were compliantnon-compliant with the study type of diapers brand cloth pull-ups type of water used to clean fresh vs well frequency of feeds diet etc
Pre-Operatively about 4 weeks prior to ostomy closure
Intervention Group
The parent or the inpatient healthcare provider if patient is hospitalized at any point within the 4 weeks prior to ostomy closure will follow standard of care for skin care pre-operatively which is either no application of barrier cream or an application of an over the counter skin barrier such as Aquaphor Desitin or Vitamin AD if the patient is experiencing skin redness from urine incontinence In addition to standard of care they will apply stool from the stoma bag 4 weeks prior twice daily for 10 minutes at a time However with the stool application no barrier cream will be applied to the skin in order for the stool to achieve penetrance to the skin After 10 minutes of application the caregiver or inpatient healthcare provider will remove the entire thin layer of stool gently without excessive friction just enough to remove the stool a dabbing motion is preferred Parents will be asked to upload images of their childs diaper area at least once weekly onto the MyCHP Portal if their child is not inpatient in order to monitor their skin for breakdown from and while performing the intervention If at any time redness occurs the parent will be asked to upload an additional picture to the MyCHP Patient Portal for investigatorclinician review or for visual inspection if inpatient and corresponding measurement of perianal skin breakdown Upon visual inspection or image inspection the co-investigator clinician will provide review corresponding measurement with a validated diaper dermatitis scale and provide appropriate clinical guidance
Compliance and Assessment A preoperative compliance log will be used with every stool application by the parent at home or healthcare provider This log will ask who applied the stool how long stool was on the skin description of stool skin description what brand of diapers and wipes were used diet information etc They will notify the researchers if there are worsening skin concerns at home Weekly and as needed images of buttocks areas will be uploaded into the CHP Patient Portal for clinicalresearch review by the parent or weekly visual inspections as needed assessments by the principal investigator or co-investigators for hospitalized patients pre-operatively On day of closure there will be a one time assessment to get a baseline assessment of skin prior to surgery Compliance logs will also be turned in at this time
Control Group
Skin care inpatient and outpatient
Will follow standard of care for skin care pre-operatively They will not be applying ostomy stool output to the skin but can apply an over the counter skin barrier such as Aquaphor Desitin or Vitamin AD if the patient is experiencing skin redness from urine incontinence One-time assessment on day of closure to ensure no application of stool to buttocks area was conducted during pre-operative period and to get a baseline assessment
------ Post Operatively Post op day 1 - 1st post-operative appt approximately 1-month Intervention Group and Control Group
Standard of care skin creams including 3M no-sting immediately post op once begin stooling- stoma powder 3M no-sting Critic-aid thick barrier paste will be applied to the skin The parents andor health care providers will use home-made wipes water moistened gauze to clean the skin Healthcare providers andor parents will provide q2h diaper checks If there is worsening of the skin condition or concerns the healthcare provider will notify the enterostomal nurse and place a new skin care consult Additional interventions suggested by the enterostomal nurse may include BIDtwice daily Aveeno soaks BID Domeboro soaks or blow by 02 to the buttocks
With each diaper change the caregiver andor the nurse will assess the childs diaper area
Twice weekly and as needed images of buttocks areas will be uploaded onto the CHP Childrens Hospital of Pittsburgh Patient Portal for both groups once outpatient The investigators will provide review and corresponding measurement with a validated diaper dermatitis scale
Weekly and as needed visual inspections of buttocks area for clinicalresearch review when still inpatient
At postoperative visit
Return of preoperative log if previously forgot The parent will fill out a questionnaire at this time There will be one more assessment of their skin at this appointment
Electronic Medical Record EMR Review An electronic medical record review will be performed to collect information necessary for this study including demographic data age gender race gestational age initial diagnosis comorbidities type of ostomy duration of ostomy reason for stoma closure heightweight percentiles at birth at closure formula vs breast milk diet at time of closure diet information inpatient vs outpatient intervention vs control length of stay medication use antibiotics cholestyramine Imodium Metamucil etc post-operative complications skin assessments any additional skin care interventions aveeno soaks domeboro soaks blow by 02 nystatin etc labs length of stay previous ostomy complicationsrevisionssurgeries and if discharged home prior to closureetc
Compliance log Compliance logs will be reviewed for the following If they were compliantnon-compliant with the study type of diapers brand cloth pull-ups type of water used to clean fresh vs well frequency of feeds diet etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None